Sr Quality Automation and CSV Engineer (Onsite)

Purpose and Scope

The Senior Automation CSV Engineer will lead the design, implementation, and validation of automated systems and new technology solutions within a sterile injectable pharmaceutical manufacturing environment. This role ensures compliance with regulatory requirements (FDA, EMA, ICH) and company standards for computerized systems, automation platforms, and AI-enabled technologies used in production, quality control, and data analytics.

Essential Duties & Responsibilities

• Automation and Computer System Validation:
  • Develop and execute validation strategies for automated systems, robotics, and AI-based tools in compliance with GAMP 5, 21 CFR Part 11, FDA’s CSA for Production and Quality System Software, Annex 11, Annex 22, and PIC/S.
  • Perform risk assessments and ensure data integrity.
  • Author and review validation documentation (URS, FS, DS, IQ/OQ/PQ protocols, reports).
• System Lifecycle Management:
  • Oversee system implementation, upgrades, and change control for automation and computer systems.
  • Collaborate with IT, Engineering, and Quality teams to maintain validated state of systems.
• Regulatory Compliance:
  • Ensure adherence to cGMP, FDA, EMA, and global regulatory guidelines for sterile injectable manufacturing.
  • Support audits and inspections by providing validation evidence and technical expertise.
• Innovation & Continuous Improvement:
  • Identify opportunities to integrate new technologies and advanced analytics for process optimization and predictive maintenance.
  • Drive digital transformation initiatives.
• Quality Oversight & Approval:
  • Provide independent quality oversight for automation and computer system validation activities.
  • Review and approve validation protocols, reports, and change control documentation to ensure compliance and data integrity.
  • Act as a quality representative during system implementation and qualification phases.
  • Adhere to company and departmental timelines with high accuracy and quality.
• Core Values:
  • Center on People: Support the well-being of patients and employees.
  • Are Proactive & Agile: Embrace change and act quickly to achieve goals.
  • Act Ethically: Conduct business ethically and comply with laws and regulations.
  • Constantly Improve: Continuously seek ways to improve products, systems, processes, and services.
  • Are Accountable: Be honest, transparent, and responsible for one's actions.

Knowledge, Skills & Abilities

• Excellent organizational and project management skills.
• Excellent oral and written communication skills.
• Ability to work independently with minimal supervision and as part of a cross-functional team.
• Advanced knowledge of Automation and CSV/CSA principles, industry guidance, regulatory requirements, cGMP practices, and ICH guidelines.
• Strong project management and cross-functional leadership skills.
• Ability to author strong technical reports free of errors.
• Advanced knowledge with Microsoft Office Suite, and various GMPS systems such as Veeva eQMS, Maximo CMMS, BMS, LIMS, CDS, and ERPs.
• Familiarity with SCADA, PLC, MES, and AI platforms from simple context analysis tools to large language modeling, prompt engineering, and the role of human interaction for process engineering and establishment of trustworthy data.
• Advanced troubleshooting and problem-solving skills.
• Ability to manage multiple projects concurrently and under tight time constraints.

Education & Experience

• Bachelor’s degree in Engineering, Computer Science, Pharmaceutical Sciences, or related field required.
• Master’s degree in Engineering, Computer Science, Pharmaceutical Sciences, or related field preferred.
• Minimum of 8 years’ experience in pharmaceutical automation and computerized system validation.
• Strong knowledge of sterile injectable manufacturing processes and aseptic techniques.
• Expertise in GAMP 5, 21 CFR Part 11, Annex 11 and knowledge of Annex 22 compliance.
• Proficiency in risk-based validation and data integrity principles.

Compensation And Benefits

Pay: $138,000 to $148,000 per year depending on experience
Bonus Eligible
Benefits information: https://www.tolmar.com/careers/employee-benefits

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.