Job Details
Posted 15 July, 2026
Job Id: 629264
Sr. QAV Specialist
Job Description
Target PR Range: 74-84/hr DOE
Responsibilities –
Provide onsite QAV support at 170 Middlesex Turnpike Gene Therapy Manufacturing facility located in Bedford, MA to support the following QAV activities for the AM805 tech transfer project:
· Review and approval of equipment, automation, facility, and utility system validation lifecycle documents for the AM805 tech transfer project including but not limited to:
o SLRA (System Level Risk Assessments)
o DI (Data Integrity) Assessments
o DR/DQ
o Specifications
o IQ/OQ/PQ Qualification Protocols
o Validation Issues
o IQ/OQ/PQ Qualification Reports
o Risk assessments
· Review and approval of BMRAM work orders for equipment, automation, facilities, and utilities.
· Independently represent QAV in cross functional project meetings.
Requirements – (List the education and experience required to perform the primary responsibilities of the job. Also include certifications, special skills, licenses, and travel requirements.):
· A B.S. degree in Engineering or other Science field such as microbiology, chemistry or biochemistry.
· Experience in biopharmaceutical or biotechnology based GMP operations with experience in Quality and/or Validation roles.
· Direct experience with facility, equipment, and utility validation is required. Experience with cell culture and single use systems is preferred.
· Knowledge of relevant FDA and EMA regulations.
· Ability and willingness to work in a fast-paced environment that will require a combination of individual contribution documentation reviews and communication of quality requirements aligned with program procedures in cross functional meetings.
· Excellent oral and written communication skills with strong technical writing experience is required.
· Excellent organizational skills and attention to detail.
* Experience with continuous improvement efforts.
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert
Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
