Job Title: Validation Engineer – APS
Location: Boston, MA
Overview:
We are seeking 2-3 local Validation Engineers with 5-8 years of experience to support ongoing validation and APS (Aseptic Process Simulations) activities. Candidates should possess strong knowledge of validation principles, demonstrate autonomy in executing APS protocols, and have experience with CQV (Commissioning, Qualification, and Validation) for maintenance activities rather than new equipment or process startups.
Key Responsibilities:
- APS Protocol Execution:
- Independently execute Aseptic Process Simulations (APS) to ensure compliance with GMP and regulatory requirements.
- Revise, update, and maintain APS protocols and associated documentation as necessary.
- Validation Documentation:
- Draft, review, and revise validation protocols, test plans, and reports, ensuring alignment with regulatory standards.
- Maintain meticulous records of validation activities for audits and inspections.
- CQV for Ongoing Maintenance:
- Support the qualification and validation of equipment and processes related to facility operations and routine maintenance.
- Perform periodic reviews and re-qualification of systems as required by internal policies.
- Compliance Assurance:
- Ensure all validation activities meet current regulatory guidelines, including FDA, EMA, and other applicable standards.
- Collaborate with Quality and Operations teams to address findings and implement corrective actions as needed.
Qualifications:
- Bachelor’s degree in Engineering, Life Sciences, or a related field.
- 5-8 years of experience in validation within a GMP-regulated environment.
- Proven experience with APS protocol execution and document management.
- Familiarity with CQV activities, particularly for maintenance and re-qualification efforts.
- Strong understanding of validation principles and regulatory compliance (e.g., FDA, ICH, EU GMP).
- Excellent written and verbal communication skills, with attention to detail and accuracy.
- Ability to work independently and manage multiple tasks within defined timelines.
Preferred:
- Prior experience with Aseptic Process Simulations or cleanroom qualification.
- Hands-on experience in the pharmaceutical or biotech industry.
- Local candidates preferred for immediate availability and minimal travel.
This opportunity is ideal for validation professionals looking to contribute to ongoing operational excellence in a GMP setting while focusing on established systems and processes.
