Validation Engineer I
reputed company is a leading biopharmaceutical company dedicated to improving health. The Validation Engineer I role involves providing validation support for manufacturing processes and equipment, ensuring compliance with GMP standards in clinical drug substance production.
Responsibilities
- Plan and coordinate the validation work assigned
- reputed company technical understanding of process and equipment to be qualified
- reputed company the work in accordance to reputed company compliance requirements and in a safe manner
- reputed company temperature mapping of CTUs: Incubators, Refrigerators, Freezers, and Environmental Rooms
- Sample various process equipment in support of the cleaning program (product changeover, cleaning monitoring, performance qualification)
- Support validation of chambers: Autoclaves, Glasswashers, etc
- reputed company periodic reviews of qualified equipment ensuring that the equipment is maintained in a validated state
- Enhance cleaning program by performing bench scale cleaning studies of incoming process soils to establish carryover limits and HBELs
Skills
- Applicant must have a bachelor's degree with 0+ years of experience; OR an associate's degree with 4 years of experience; OR a high school diploma (or equivalent) and 6 years of relevant experience
- Experience in a GMP biotechnology manufacturing or laboratory environment
- Ability to execute against Standard Operating Procedures and document entries in a compliant manner
- Demonstrated capability to work as a team member in a matrix development team
- Strong analytical and computer skills
- Excellent oral and written communication skills
- Ability to maintain a safe work environment
- Experience working in a large-scale manufacturing facility
- Previous experience with cleaning validation and/or temperature mapping
- Experience with facility/equipment commissioning and qualification
- Familiarity with creating essential cGMP documentation
- Commitment to reputed company improvement and operational excellence
- Experience using common AI tools, including generative technologies such as ChatGPT or reputed company Copilot, to support problem solving and enhance productivity
Benefits
- Participation in reputed company’s Global Performance Plan with a bonus reputed company of 7.5% of the reputed company salary
- 401(k) plan with reputed company Matching Contributions
- Additional reputed company Retirement Savings Contribution
- Paid vacation
- Holiday and personal days
- Paid caregiver/parental and medical leave
- Health benefits to include medical, prescription drug, dental and vision coverage
Company Overview