Join a premier viral vector manufacturing facility in Carlsbad, CA, as a Lead Process Validation Engineer. In this dynamic CMO environment, you will drive process validation strategy, manage execution, and serve as the technical subject matter expert for cell and gene therapy manufacturing operations.
location: Carlsbad, California
job type: Contract
salary: $57 - 72 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Define and implement robust Process Validation, Process Performance Qualification (PPQ), and Continued Process Verification (CPV) frameworks.
- Write complex risk assessments, manage validation impact assessments, and investigate process deviations to prevent repeat events.
- Lead studies on process hold times, homogeneity, and mixing, establishing drug substance manufacturing control strategies.
- Generate, review, and approve critical validation protocols, reports, and technical documentation.
- Serve as the Process Validation SME during customer meetings, regulatory audits, and cross-functional technical liaison efforts.
qualifications:
Required:
- Bachelor's or Master's degree in Biochemistry, Chemistry, Chemical Engineering, Microbiology, or related Life Sciences field.
- 7+ years of experience in a cGMP manufacturing environment.
- 5+ years of dedicated experience in Process Validation, PPQ, and CPV strategies.
- 10+ years of process validation experience in a cGMP setting.
- 5+ years of hands-on experience with cell culture upstream operations (bioreactors, clarification) or downstream purification (TFF, automated chromatography skids, sterile filtration).
- Strong technical writing abilities and experience leading cross-functional teams without direct authority.
skills: Chemistry, Microbiology, Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
