Specialist, Engineering (Onsite)
Merck · Durham, NC · 1 mo ago
Engineering$87k–$137k/yrFull-time
We need to output HTML fragment with sections: headings for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections if posting has real specific content. We must not repeat job title. Must not include Job ID etc. Must preserve all substantive info, remove boilerplate, navigation, legal, EEO, etc. Also remove application instructions, duplicated lines, cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate. Also remove "Current Employees apply HERE", etc. Also remove "US And Puerto Rico Residents Only", etc. Also remove "Requirements As an Equal Employment Opportunity Employer..." etc. Also remove "Search Firm Representatives Please Read Carefully..." etc. Also remove "Employee Status Regular Relocation: Domestic VISA Sponsorship No Travel Requirements 10% Flexible Work Arrangements Not Applicable Shift 1st - Day, 2nd - Evening Valid Driving License No Hazardous Material(s) n/a Job Posting End Date 09/26/2026 ..." etc. Also remove "A job posting is effective until..." etc. Also remove "Requisition ID:R415455". Also remove "Current Employees apply HERE Current Contingent Workers apply HERE". Also remove "US And Puerto Rico Residents Only". Also remove "Our company is committed to inclusion..." etc. Also remove "Please click here if you need an accommodation..." etc. Also remove "As an Equal Employment Opportunity Employer..." etc. Also remove "We are proud to be a company..." etc. Also remove "The fastest way to breakthrough innovation..." etc. Also remove "Learn more about your rights..." etc. Also remove "San Francisco Residents Only..." etc. Also remove "Los Angeles Residents Only..." etc. Also remove "Search Firm Representatives Please Read Carefully..." etc. Also remove "Employee Status Regular Relocation: Domestic VISA Sponsorship No Travel Requirements 10% Flexible Work Arrangements Not Applicable Shift 1st - Day, 2nd - Evening Valid Driving License No Hazardous Material(s) n/a Job Posting End Date 09/26/2026 ..." etc.
We need to keep substantive info: description of FLEx Sterile, location rotation, responsibilities at Durham site, responsibilities at Rahway site (Technical Operations, Pharm Ops Engineering - Equipment, Pharm Ops Engineering - Automation), education minimum requirements, required experience and skills, preferred experience and skills, required skills list, preferred skills list, salary range, benefits description, maybe mention bonus and long-term incentive. Also mention that role requires on-site support. Also mention that relocation after 12-18 months not considered termination.
We need to structure sections: maybe About the role (summary), Responsibilities (maybe combine Durham and Rahway responsibilities), Requirements (education + required experience/skills), Qualifications (maybe preferred experience/skills?), Skills (maybe required skills list?), Benefits, Pay, Schedule? Schedule not mentioned; we should not create Schedule section unless posting actually states it. No schedule info. So omit Schedule.
Pay: we have salary range $87,300 - $137,400 and mention annual bonus and long-term incentive. So include Pay section.
Benefits: we have comprehensive package: medical, dental, vision, retirement 401(k), paid holidays, vacation, compassionate and sick days. Also link to benefits page but we can just describe.
We need to avoid duplication. Use
for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections if posting has real specific content. We must not repeat job title. Must not include Job ID etc. Must preserve all substantive info, remove boilerplate, navigation, legal, EEO, etc. Also remove application instructions, duplicated lines, cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate. Also remove "Current Employees apply HERE", etc. Also remove "US And Puerto Rico Residents Only", etc. Also remove "Requirements As an Equal Employment Opportunity Employer..." etc. Also remove "Search Firm Representatives Please Read Carefully..." etc. Also remove "Employee Status Regular Relocation: Domestic VISA Sponsorship No Travel Requirements 10% Flexible Work Arrangements Not Applicable Shift 1st - Day, 2nd - Evening Valid Driving License No Hazardous Material(s) n/a Job Posting End Date 09/26/2026 ..." etc. Also remove "A job posting is effective until..." etc. Also remove "Requisition ID:R415455". Also remove "Current Employees apply HERE Current Contingent Workers apply HERE". Also remove "US And Puerto Rico Residents Only". Also remove "Our company is committed to inclusion..." etc. Also remove "Please click here if you need an accommodation..." etc. Also remove "As an Equal Employment Opportunity Employer..." etc. Also remove "We are proud to be a company..." etc. Also remove "The fastest way to breakthrough innovation..." etc. Also remove "Learn more about your rights..." etc. Also remove "San Francisco Residents Only..." etc. Also remove "Los Angeles Residents Only..." etc. Also remove "Search Firm Representatives Please Read Carefully..." etc. Also remove "Employee Status Regular Relocation: Domestic VISA Sponsorship No Travel Requirements 10% Flexible Work Arrangements Not Applicable Shift 1st - Day, 2nd - Evening Valid Driving License No Hazardous Material(s) n/a Job Posting End Date 09/26/2026 ..." etc.
We need to keep substantive info: description of FLEx Sterile, location rotation, responsibilities at Durham site, responsibilities at Rahway site (Technical Operations, Pharm Ops Engineering - Equipment, Pharm Ops Engineering - Automation), education minimum requirements, required experience and skills, preferred experience and skills, required skills list, preferred skills list, salary range, benefits description, maybe mention bonus and long-term incentive. Also mention that role requires on-site support. Also mention that relocation after 12-18 months not considered termination.
We need to structure sections: maybe About the role (summary), Responsibilities (maybe combine Durham and Rahway responsibilities), Requirements (education + required experience/skills), Qualifications (maybe preferred experience/skills?), Skills (maybe required skills list?), Benefits, Pay, Schedule? Schedule not mentioned; we should not create Schedule section unless posting actually states it. No schedule info. So omit Schedule.
Pay: we have salary range $87,300 - $137,400 and mention annual bonus and long-term incentive. So include Pay section.
Benefits: we have comprehensive package: medical, dental, vision, retirement 401(k), paid holidays, vacation, compassionate and sick days. Also link to benefits page but we can just describe.
We need to avoid duplication. Use - for any list of duties/requirements/benefits. Use
for prose.
We must not repeat job title as heading. So we start with maybe
About the role
then paragraph summarizing.
Then Responsibilities
then maybe combine Durham and Rahway responsibilities into lists.
But we need to ensure we don't create sections with filler. All sections must have real content.
Let's extract substantive content:
From posting:
- The Formulation, Laboratory, and Experimentation (FLEx) Center in Rahway, New Jersey, features a cutting-edge sterile drug product cGMP clinical supply manufacturing facility, known as FLEx Sterile. The FLEx Sterile 2 facility expansion is a strategic capital project designed to significantly enhance clinical supply manufacturing capacity by adding a second sterile filling and lyophilization suite, a formulation suite, a sterile supply suite, and supporting infrastructure and utilities.
- The Durham, North Carolina site is a commercial vaccine manufacturing facility with drug substance, drug product, and sterile supply manufacturing operations, and supporting infrastructure and utilities.
- The Specialist Engineer position will initially be based in Durham, NC for approximately 12 to 18 months to support business needs. After completion of this initial 12-to-18-month period, the role will relocate to Rahway, NJ based on business needs. This location change will not be considered a “termination of employment due to a restructuring” as defined in the company's US Employee Separation Benefit Plan. The role will require on-site support.
- Durham Site: The 12 to 18 month rotation at the Durham, NC site will allow the Specialist Engineer to gain experience supporting commercial drug product manufacturing operations including formulation, filling, lyophilization, and visual inspection. Responsibilities at the Durham site will be based on business needs and may include but are not limited to shop floor equipment and automation troubleshooting, deviation investigation support, change controls, equipment validation, technical protocol authoring and execution, and equipment maintenance.
- Rahway Site: FLEx 2 is a strategic expansion that will increase sterile clinical manufacturing capacity through additional filling, lyophilization, formulation, and supporting utility suites. These roles provide technical support across formulation, process development, manufacturing, equipment, and automation to ensure GMP compliance, operational readiness, and efficient, reliable sterile drug product operations.
Then sub-sections:
Technical Operations (FLEx Tech Ops):
- Serve as technical SME for formulation, process development, and scale-up activities.
- Support manufacturing by authoring quality investigations, change controls, SOPs, and technical protocols required to support clinical drug product operations.
- Contribute the execution of the commissioning, qualification, and regulatory certification of the FLEx Sterile GMP Clinical Manufacturing facility.
- Collaborate closely with the formulation scientists, engineers, quality representatives, and other team members to ensure the quality of the clinical supplies, the scientific rigor of the processes, and ultimately to enable the flexibility and speed of our Company's pipeline.
- Work with a variety of state-of-the-art aseptic drug product formulation, filling, and lyophilization equipment while completing processes throughout the manufacturing cycle
- Manage individual project assignments and aid in facility and process equipment innovation.
- Perform manual and/or automated operations, general maintenance, troubleshooting and support functions
Pharm Ops Engineering (POE) - Equipment:
- Serve as a technical SME for equipment troubleshooting, maintenance, and coordination with engineering, utilities, facilities, OEM vendors, and contractors.
- Support Quality Engineering and capital projects, including equipment installation, commissioning, validation, and lifecycle management.
- Lead sterilization and cleaning validation programs by authoring and reviewing validation documents, coordinating execution activities, conducting technical assessments, and supporting regulatory inspections as a validation SME.
- Own change management, periodic reviews, deviation investigations, root cause analyses, and CAPA implementation while maintaining GMP documentation.
- Maintain GMP-compliant facilities, utilities, and manufacturing equipment using reliability maintenance practices, tracking calibrations and PMs, and assisting with shutdown planning and execution.
- Manage operational and administrative activities including work order oversight, contractor coordination, purchase orders, budgets, asset tracking, and project closeout activities.
Pharm Ops Engineering (POE) - Automation:
- Maintain validated and compliant automation systems for sterile manufacturing, ensuring adherence to GMP, data integrity, cybersecurity, and lifecycle management requirements.
- Provide automation support for formulation, filling, and lyophilization operations, including troubleshooting, root cause analysis, reliability improvements, and on-floor manufacturing support.
- Lead automation change management, investigations, CAPAs, periodic reviews, and regulatory inspection readiness while maintaining automation documentation and system configurations.
- Support capital projects and new product introductions by leading automation design, integration, FAT/SAT, commissioning, qualification (AIOQ), and acceptance testing activities.
- Manage automation system strategy and lifecycle planning, including upgrades, expansions, obsolescence remediation, OT/IT architecture, cybersecurity, backups, and disaster recovery.
- Develop data, reporting, and visualization solutions while collaborating with manufacturing, quality, facilities, engineering, IT, and external vendors to drive operational excellence and continuous improvement.
Education Minimum Requirements:
- B.S. Degree in Chemical/Bio-Chemical Engineering or Chemistry/Biological Sciences or related disciplines. with a minimum of 2 years of relevant experience.
Required Experience And Skills:
- Familiarity with United States and European Union GMP and safety compliance regulations.
- Strong problem-solving skills and ability to work independently.
- Strong organizational skills with the ability to manage multiple priorities and deadlines.
- Ability to collaborate effectively with cross-functional teams and stakeholders.
- Excellent verbal and written communication skills.
Preferred Experience And Skills:
- Project management
- Cross functional leadership
- Change Control
- Deviation Management
- Strong technical writing
- Sterile process manufacturing, sterile drug product and/or formulation development
- #eligibleforERP #PSCS FLEx2026 Sterile2026 (these seem like tags, maybe ignore)
Required Skills (list):
- Electronic Batch Records, Equipment Maintenance, Operation Maintenance, Pilot Plant Operations, Process Engineering, Process Manufacturing, Product Formulation, Root Cause Identification, Sterile Manufacturing, Troubleshooting
Preferred Skills:
- Clinical Manufacturing, Drug Product Manufacturing, Manufacturing Operations
Salary: The salary range for this role is $87,300.00 - $137,400.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
Benefits: We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
We should not include the link maybe but can keep as prose? The instruction: preserve ALL substantive information; do NOT invent or summarize away detail. The link is substantive? It's a reference for more info. Might be considered boilerplate? It's a URL to benefits page. Might be okay to keep but it's not a list. Could include as part of benefits paragraph.
We must remove application instructions: "You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting." etc. Also remove "Current Employees apply HERE Current Contingent Workers apply HERE". Also remove "US And Puerto Rico Residents Only". Also remove "Please click here if you need an accommodation during the application or hiring process." etc. Also remove "As an Equal Employment Opportunity Employer..." etc. Also remove "Search Firm Representatives Please Read Carefully..." etc. Also remove "Employee Status Regular Relocation: Domestic VISA Sponsorship No Travel Requirements 10% Flexible Work Arrangements Not Applicable Shift 1st - Day, 2nd - Evening Valid Driving License No Hazardous Material(s) n/a Job Posting End Date 09/26/2026 ..." etc. Also remove "A job posting is effective until..." etc. Also remove "Requisition ID:R415455". Also remove "#eligibleforERP #PSCS FLEx2026 Sterile2026" maybe treat as tags not substantive; could drop.
We need to ensure we don't inadvertently keep any boilerplate lines like "
for prose. We must not repeat job title as heading. So we start with maybe