Job description
Position Title: Validation Engineer
Department: Quality Division
Report Line: HOD
Travel: 20-50% within the 2 sites (Somerset, NJ /Monroe, NJ)
Reporting to the Director, QM the Validation Engineer coordinates all validation activities across multiple Access Bio sites in NJ.
Roles and Responsibilities:
- Ensure all equipment and manufacturing processes are qualified and validated to internal, external and industry standards.
- Establish all aspects of a validation project; including: authoring/reviewing/executing Validation Master Plan (VMP) and Procedure, Validation Plan (VP), User Requirements Specifications (URS), Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols / report, risk assessments, and periodic validation / qualification reviews.
- Work with production, facilities, R&D, engineering, purchasing, etc. in the development, execution and change control of validation protocols.
- Submit timely reports regarding scope and status of validation activity
- Maintain up-to-date knowledge of validation requirements, practices, and procedures and coach other members of the team participating in validation activities.
Education:
Minimum of BS in Science or Engineering, Post-graduation a plus.
Qualification:
- Minimum of 3 years’ experience writing and executing validation documents, IQ/OQ/PQ protocols.
- Experience with both conventional CNC and robotic manufacturing processes
- Previous experience working in a highly regulated environment is a must
- Knowledge of Good Manufacturing Practices.
- Good understanding of measurement system analysis including GR&R
- Understanding of ISO 13485 and FDA 21 CFR part 820 preferred
- Proficiency with various software programs; including word processing, spreadsheet, and database applications.
- Excellent organizational skills, with the ability to handle multiple priorities and deadlines.
- Excellent verbal and communication skills.
ACCESS BIO is an Equal Opportunity Employer. We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law.
Job Type: Full-time
Pay: From $70,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
- Relocation assistance
- Vision insurance
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
- Overtime
Work Location: One location
gatheringourvoice.org is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, gatheringourvoice.org provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, gatheringourvoice.org is the ideal place to find your next job.