Director, Engineering, Validation & Maintenance
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). We should include sections only if posting has real specific content. The posting includes: Job Summary (we can map to About the role). Responsibilities (multiple bullet-like paragraphs). Qualifications (Bachelor’s degree...). Knowledge, Skills, And Abilities (that's Skills). Also there is "Leadership And Business Skills", "Reliability and Operational Excellence". Those could be part of Skills or separate sections? Probably combine into Skills section. Benefits, Pay, Schedule: we have schedule: "On-Site Expectations 100% on-site position. 1st Shift: Monday - Friday, 8:00am - 5:00pm." That's schedule info. So we can create a Schedule section with that content. Benefits: not mentioned. Pay: not mentioned. So omit Benefits and Pay.
We must not repeat job title as heading. No Job ID.
We must preserve all substantive info. Use - for any list of duties/requirements/benefits. The responsibilities are paragraphs but could be turned into list items? The instruction: use
- for any list of duties/requirements/benefits. The responsibilities are not explicitly a list but we can treat each bullet as list item. However the text is paragraph sentences; we could still wrap each responsibility in
- . But we need to decide: The instruction says use
- for any list of duties/requirements/benefits. If the posting does not have explicit list markers, we could still create a list from the sentences. Safer: we can keep responsibilities as
paragraphs? But instruction says use
- for any list of duties/requirements/benefits. It might be safer to convert each distinct duty into
- . We'll parse responsibilities section: It has multiple paragraphs each starting with a bold heading? Actually the text: "Leadership, Strategy, and Organizational Development Develop, implement, and continuously improve ..." then "Engineering and Technical Operations Provide strategic and technical leadership..." etc. These are sections within responsibilities. We could treat each as a list item.
Similarly Qualifications: bullet-like lines: "Bachelor’s degree... required.", "10+ years...", "6+ years...", "Prior pharmaceutical experience required; prior CDMO experience preferred." We'll make list.
Skills: The "Knowledge, Skills, And Abilities" section includes many bullet-like sentences separated by periods. Could make list.
We also have other sub-sections like "Leadership And Business Skills", "Reliability and Operational Excellence". Might be part of Skills.
We'll create sections:
About the role
with the Job Summary paragraph(s). Could be multiple paragraphs; we can combine into .
Responsibilities
with - items.
Qualifications
with - .
Skills
with - (combining Knowledge, Skills, And Abilities plus Leadership And Business Skills plus Reliability and Operational Excellence maybe).
Schedule
with containing the on-site expectations.
We must not include Benefits or Pay.
We must output only HTML fragment.
Let's extract content precisely.
Job Summary paragraph(s):
"At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary The Director, Engineering, Validation and Maintenance is responsible for the strategic leadership, development, and execution of engineering, validation, maintenance, reliability, and manufacturing automation programs that support current operations and future growth of the site. This role provides end-to-end lifecycle ownership of facility, utility, manufacturing, laboratory, and automation systems, ensuring regulatory compliance, operational excellence, asset reliability, and business continuity. The Director leads all aspects of engineering, including capital project planning and execution, facility and utility design, equipment procurement, installation, commissioning, and lifecycle management. The role oversees validation activities, including commissioning, qualification (IQ/OQ/PQ), computerized system validation, and ongoing requalification programs. Additionally, the position is responsible for site maintenance, metrology, and reliability engineering programs focused on maximizing equipment uptime, optimizing asset performance, reducing operational risk, and implementing predictive and reliability-centered maintenance strategies. The role also provides leadership for manufacturing automation and digital infrastructure, including process control systems, SCADA, PLCs, manufacturing data systems, historian platforms, and computerized systems that support GMP manufacturing operations. The Director drives automation and digital transformation initiatives that improve process robustness, data integrity, operational efficiency, and manufacturing scalability. As a key member of the site leadership team, the Director develops and executes long-range capital and infrastructure strategies while ensuring facility, utility, contamination control, and automation systems remain aligned with current regulatory expectations and business objectives. The position serves as a technical leader during client interactions, regulatory inspections, and corporate initiatives, while building organizational capability through talent development, succession planning, and continuous improvement. This role fosters a culture of safety, quality, compliance, reliability, innovation, and operational excellence by leveraging modern engineering practices, Lean principles, risk-based decision-making, and cross-functional collaboration to support the successful delivery of sterile pharmaceutical manufacturing operations."
We can keep as one
.
Now Responsibilities: The text after "Responsibilities" heading includes multiple sections:
"Leadership, Strategy, and Organizational Development Develop, implement, and continuously improve site engineering, validation, maintenance, metrology, reliability, and automation strategies that support current operations, future growth, compliance, and operational excellence objectives.Establish departmental goals, key performance indicators (KPIs), and long-range strategic plans aligned with business objectives and network standards.Build, develop, and retain a high-performing technical organization through effective leadership, coaching, mentoring, succession planning, and talent development.Foster a culture of safety, quality, accountability, innovation, operational excellence, and continuous improvement.Represent the department on site leadership teams, governance forums, client meetings, audits, inspections, and cross-functional initiatives.Develop and manage departmental operating budgets and long-range capital investment plans."
"Engineering and Technical Operations Provide strategic and technical leadership for facility, utility, manufacturing, laboratory, and process support systems throughout the asset lifecycle.Oversee engineering activities including conceptual design, scope development, budgeting, procurement, construction management, installation, commissioning, startup, and lifecycle management.Ensure equipment, facility, utility, and automation systems are designed, maintained, and operated in accordance with cGMP, regulatory requirements, corporate standards, and industry best practices.Serve as the site subject matter expert (SME) for facility infrastructure, clean utilities, process equipment, contamination control systems, and critical GMP support systems.Support sterile manufacturing operations through effective management of engineering resources and technical problem-solving."
"Validation and Compliance Oversee facility, utility, equipment, process, and computerized system validation programs.Ensure execution of commissioning, qualification, and validation activities including FAT, SAT, IQ, OQ, PQ, requalification, and periodic review programs.Partner with Quality to maintain compliant validation systems aligned with cGMP, FDA, EMA, ICH, ISPE, and corporate requirements.Support internal audits, customer audits, and regulatory inspections while ensuring timely completion of commitments and corrective actions.Drive continuous improvement of validation lifecycle management and risk-based qualification practices."
"Reliability Engineering and Asset Management Establish and maintain a Reliability Engineering program focused on maximizing equipment availability, minimizing downtime, and reducing lifecycle costs.Develop and monitor key reliability metrics including equipment uptime, schedule compliance, and asset utilization.Assist with root cause investigations and corrective actions related to equipment failures, recurring deviations, and operational losses.Drive asset lifecycle management strategies to optimize performance, reliability, maintainability, and regulatory compliance."
"Maintenance and Facilities Operations Provide leadership and oversight for campus maintenance programs, including preventive, predictive, corrective, and emergency maintenance activities.Ensure effective execution of work management processes, planning and scheduling systems, spare parts management, and CMMS utilization.Lead facility programs including security systems, contractor management, building maintenance, grounds management, housekeeping oversight, pest control, and infrastructure sustainability.Ensure facility and utility systems are maintained in a state of inspection readiness and operational reliability."
"Manufacturing Automation and Digital Systems Lead site manufacturing automation strategy, governance, and execution to support operational excellence and digital transformation initiatives.Provide oversight for automation systems including PLCs, SCADA, DCS, HMI, historian platforms, manufacturing data systems, and related computerized systems.Partner with Operations, Quality, IT, and MS&T to implement automation solutions that improve process robustness, data integrity, efficiency, and scalability.Drive modernization of manufacturing systems through digital technologies, advanced analytics, system integration, and automation lifecycle management.Ensure automation systems comply with applicable regulatory requirements, data integrity standards, cybersecurity expectations, and validation requirements."
"Metrology and Calibration Lead the site metrology function, ensuring effective calibration, maintenance, repair, and lifecycle management of critical instruments and measurement systems.Maintain compliant calibration systems that support manufacturing, laboratory, facility, and utility operations.Drive continuous improvement initiatives that enhance measurement accuracy, reliability, and operational efficiency."
"Business Continuity, Sustainability, and Risk Management Lead engineering aspects of business continuity planning, disaster recovery preparedness, infrastructure redundancy, and risk mitigation strategies.Support and advance site sustainability and ESG initiatives through energy management, utility optimization, refrigerant stewardship, and environmental improvement projects.Assess operational and technical risks and implement mitigation strategies to ensure business continuity and regulatory compliance."
"People Leadership Directly lead engineering, validation, maintenance, reliability, metrology, and automation leaders and their associated teams.Establish clear performance expectations and accountability measures.Conduct hiring, performance management, coaching, development, succession planning, and employee engagement activities.Ensure all personnel maintain required technical competencies, training qualifications, and compliance requirements.Promote a highly engaged, inclusive, and performance-driven culture focused on safety, quality, service, and operational excellence."
"Additional Responsibilities Independently make strategic and operational decisions impacting site infrastructure, compliance, reliability, and manufacturing capability.Utilize data-driven decision making, Lean principles, and continuous improvement methodologies to enhance performance.Other duties as assigned."
We'll turn each of these sections into
- . Might be many items; okay.
Now Qualifications:
"Bachelor’s degree in Engineering, Chemical, Mechanical, Biochemical, or equivalent required.10+ years of related experience required.6+ years of people leadership experience required.Prior pharmaceutical experience required; prior CDMO experience preferred."
We'll make list items each sentence.
Now Skills: combine "Knowledge, Skills, And Abilities", "Leadership And Business Skills", "Reliability and Operational Excellence". Let's extract sentences.
Knowledge, Skills, And Abilities paragraph:
"Technical Knowledge Expert knowledge of pharmaceutical engineering, facilities, utilities, maintenance, reliability engineering, validation lifecycle management, and manufacturing automation within GMP-regulated environments.Advanced knowledge of sterile manufacturing operations, aseptic processing systems, cleanroom operations, and critical utility systems.Extensive knowledge of cGMP regulations, FDA, EU GMP Annex 1, ICH, ISPE, ASTM, and industry best practices applicable to pharmaceutical manufacturing facilities.Strong understanding of equipment lifecycle management, asset reliability, risk management, and continuous improvement methodologies.Advanced knowledge of commissioning, qualification, validation, and computerized system validation (CSV) principles, including FAT, SAT, IQ, OQ, PQ, and ongoing lifecycle management.Strong understanding of clean utilities and critical infrastructure systems including HVAC, purified water, WFI, clean steam, compressed gases, and environmental monitoring systems.Working knowledge of quality systems including deviations, CAPA, change control, risk assessments, and audit management.Knowledge of process control systems, PLCs, SCADA, DCS, HMIs, manufacturing execution systems (MES), historian platforms, and industrial automation technologies.Knowledge of data integrity, cybersecurity principles,
- for any list of duties/requirements/benefits. The responsibilities are not explicitly a list but we can treat each bullet as list item. However the text is paragraph sentences; we could still wrap each responsibility in
- . But we need to decide: The instruction says use
- for any list of duties/requirements/benefits. If the posting does not have explicit list markers, we could still create a list from the sentences. Safer: we can keep responsibilities as
paragraphs? But instruction says use
- for any list of duties/requirements/benefits. It might be safer to convert each distinct duty into
- . We'll parse responsibilities section: It has multiple paragraphs each starting with a bold heading? Actually the text: "Leadership, Strategy, and Organizational Development Develop, implement, and continuously improve ..." then "Engineering and Technical Operations Provide strategic and technical leadership..." etc. These are sections within responsibilities. We could treat each as a list item.
Similarly Qualifications: bullet-like lines: "Bachelor’s degree... required.", "10+ years...", "6+ years...", "Prior pharmaceutical experience required; prior CDMO experience preferred." We'll make list.
Skills: The "Knowledge, Skills, And Abilities" section includes many bullet-like sentences separated by periods. Could make list.
We also have other sub-sections like "Leadership And Business Skills", "Reliability and Operational Excellence". Might be part of Skills.
We'll create sections:
About the role
with the Job Summary paragraph(s). Could be multiple paragraphs; we can combine into.
Responsibilities
with- items.
Qualifications
with- .
Skills
with- (combining Knowledge, Skills, And Abilities plus Leadership And Business Skills plus Reliability and Operational Excellence maybe).
Schedule
withcontaining the on-site expectations. We must not include Benefits or Pay. We must output only HTML fragment. Let's extract content precisely. Job Summary paragraph(s): "At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary The Director, Engineering, Validation and Maintenance is responsible for the strategic leadership, development, and execution of engineering, validation, maintenance, reliability, and manufacturing automation programs that support current operations and future growth of the site. This role provides end-to-end lifecycle ownership of facility, utility, manufacturing, laboratory, and automation systems, ensuring regulatory compliance, operational excellence, asset reliability, and business continuity. The Director leads all aspects of engineering, including capital project planning and execution, facility and utility design, equipment procurement, installation, commissioning, and lifecycle management. The role oversees validation activities, including commissioning, qualification (IQ/OQ/PQ), computerized system validation, and ongoing requalification programs. Additionally, the position is responsible for site maintenance, metrology, and reliability engineering programs focused on maximizing equipment uptime, optimizing asset performance, reducing operational risk, and implementing predictive and reliability-centered maintenance strategies. The role also provides leadership for manufacturing automation and digital infrastructure, including process control systems, SCADA, PLCs, manufacturing data systems, historian platforms, and computerized systems that support GMP manufacturing operations. The Director drives automation and digital transformation initiatives that improve process robustness, data integrity, operational efficiency, and manufacturing scalability. As a key member of the site leadership team, the Director develops and executes long-range capital and infrastructure strategies while ensuring facility, utility, contamination control, and automation systems remain aligned with current regulatory expectations and business objectives. The position serves as a technical leader during client interactions, regulatory inspections, and corporate initiatives, while building organizational capability through talent development, succession planning, and continuous improvement. This role fosters a culture of safety, quality, compliance, reliability, innovation, and operational excellence by leveraging modern engineering practices, Lean principles, risk-based decision-making, and cross-functional collaboration to support the successful delivery of sterile pharmaceutical manufacturing operations." We can keep as one
. Now Responsibilities: The text after "Responsibilities" heading includes multiple sections: "Leadership, Strategy, and Organizational Development Develop, implement, and continuously improve site engineering, validation, maintenance, metrology, reliability, and automation strategies that support current operations, future growth, compliance, and operational excellence objectives.Establish departmental goals, key performance indicators (KPIs), and long-range strategic plans aligned with business objectives and network standards.Build, develop, and retain a high-performing technical organization through effective leadership, coaching, mentoring, succession planning, and talent development.Foster a culture of safety, quality, accountability, innovation, operational excellence, and continuous improvement.Represent the department on site leadership teams, governance forums, client meetings, audits, inspections, and cross-functional initiatives.Develop and manage departmental operating budgets and long-range capital investment plans." "Engineering and Technical Operations Provide strategic and technical leadership for facility, utility, manufacturing, laboratory, and process support systems throughout the asset lifecycle.Oversee engineering activities including conceptual design, scope development, budgeting, procurement, construction management, installation, commissioning, startup, and lifecycle management.Ensure equipment, facility, utility, and automation systems are designed, maintained, and operated in accordance with cGMP, regulatory requirements, corporate standards, and industry best practices.Serve as the site subject matter expert (SME) for facility infrastructure, clean utilities, process equipment, contamination control systems, and critical GMP support systems.Support sterile manufacturing operations through effective management of engineering resources and technical problem-solving." "Validation and Compliance Oversee facility, utility, equipment, process, and computerized system validation programs.Ensure execution of commissioning, qualification, and validation activities including FAT, SAT, IQ, OQ, PQ, requalification, and periodic review programs.Partner with Quality to maintain compliant validation systems aligned with cGMP, FDA, EMA, ICH, ISPE, and corporate requirements.Support internal audits, customer audits, and regulatory inspections while ensuring timely completion of commitments and corrective actions.Drive continuous improvement of validation lifecycle management and risk-based qualification practices." "Reliability Engineering and Asset Management Establish and maintain a Reliability Engineering program focused on maximizing equipment availability, minimizing downtime, and reducing lifecycle costs.Develop and monitor key reliability metrics including equipment uptime, schedule compliance, and asset utilization.Assist with root cause investigations and corrective actions related to equipment failures, recurring deviations, and operational losses.Drive asset lifecycle management strategies to optimize performance, reliability, maintainability, and regulatory compliance." "Maintenance and Facilities Operations Provide leadership and oversight for campus maintenance programs, including preventive, predictive, corrective, and emergency maintenance activities.Ensure effective execution of work management processes, planning and scheduling systems, spare parts management, and CMMS utilization.Lead facility programs including security systems, contractor management, building maintenance, grounds management, housekeeping oversight, pest control, and infrastructure sustainability.Ensure facility and utility systems are maintained in a state of inspection readiness and operational reliability." "Manufacturing Automation and Digital Systems Lead site manufacturing automation strategy, governance, and execution to support operational excellence and digital transformation initiatives.Provide oversight for automation systems including PLCs, SCADA, DCS, HMI, historian platforms, manufacturing data systems, and related computerized systems.Partner with Operations, Quality, IT, and MS&T to implement automation solutions that improve process robustness, data integrity, efficiency, and scalability.Drive modernization of manufacturing systems through digital technologies, advanced analytics, system integration, and automation lifecycle management.Ensure automation systems comply with applicable regulatory requirements, data integrity standards, cybersecurity expectations, and validation requirements." "Metrology and Calibration Lead the site metrology function, ensuring effective calibration, maintenance, repair, and lifecycle management of critical instruments and measurement systems.Maintain compliant calibration systems that support manufacturing, laboratory, facility, and utility operations.Drive continuous improvement initiatives that enhance measurement accuracy, reliability, and operational efficiency." "Business Continuity, Sustainability, and Risk Management Lead engineering aspects of business continuity planning, disaster recovery preparedness, infrastructure redundancy, and risk mitigation strategies.Support and advance site sustainability and ESG initiatives through energy management, utility optimization, refrigerant stewardship, and environmental improvement projects.Assess operational and technical risks and implement mitigation strategies to ensure business continuity and regulatory compliance." "People Leadership Directly lead engineering, validation, maintenance, reliability, metrology, and automation leaders and their associated teams.Establish clear performance expectations and accountability measures.Conduct hiring, performance management, coaching, development, succession planning, and employee engagement activities.Ensure all personnel maintain required technical competencies, training qualifications, and compliance requirements.Promote a highly engaged, inclusive, and performance-driven culture focused on safety, quality, service, and operational excellence." "Additional Responsibilities Independently make strategic and operational decisions impacting site infrastructure, compliance, reliability, and manufacturing capability.Utilize data-driven decision making, Lean principles, and continuous improvement methodologies to enhance performance.Other duties as assigned." We'll turn each of these sections into
- . Might be many items; okay. Now Qualifications: "Bachelor’s degree in Engineering, Chemical, Mechanical, Biochemical, or equivalent required.10+ years of related experience required.6+ years of people leadership experience required.Prior pharmaceutical experience required; prior CDMO experience preferred." We'll make list items each sentence. Now Skills: combine "Knowledge, Skills, And Abilities", "Leadership And Business Skills", "Reliability and Operational Excellence". Let's extract sentences. Knowledge, Skills, And Abilities paragraph: "Technical Knowledge Expert knowledge of pharmaceutical engineering, facilities, utilities, maintenance, reliability engineering, validation lifecycle management, and manufacturing automation within GMP-regulated environments.Advanced knowledge of sterile manufacturing operations, aseptic processing systems, cleanroom operations, and critical utility systems.Extensive knowledge of cGMP regulations, FDA, EU GMP Annex 1, ICH, ISPE, ASTM, and industry best practices applicable to pharmaceutical manufacturing facilities.Strong understanding of equipment lifecycle management, asset reliability, risk management, and continuous improvement methodologies.Advanced knowledge of commissioning, qualification, validation, and computerized system validation (CSV) principles, including FAT, SAT, IQ, OQ, PQ, and ongoing lifecycle management.Strong understanding of clean utilities and critical infrastructure systems including HVAC, purified water, WFI, clean steam, compressed gases, and environmental monitoring systems.Working knowledge of quality systems including deviations, CAPA, change control, risk assessments, and audit management.Knowledge of process control systems, PLCs, SCADA, DCS, HMIs, manufacturing execution systems (MES), historian platforms, and industrial automation technologies.Knowledge of data integrity, cybersecurity principles,
- (combining Knowledge, Skills, And Abilities plus Leadership And Business Skills plus Reliability and Operational Excellence maybe).
- .
- items.
- for any list of duties/requirements/benefits. If the posting does not have explicit list markers, we could still create a list from the sentences. Safer: we can keep responsibilities as