CSV Engineer II/III
New Hampshire
If you thrive in fast-paced, structured environments, if you're a driven self-starter, if you're seeking team engagement, then look no further. You'll work with one of the leading CDMOs in the world, with decades of experience and a track record of repeated organic growth and a long history of the development of state-of-the-art pharmaceuticals and medical devices. This institution specializes in treatments for diabetes, communicable diseases, cancers and many other illnesses, and distributes them to over 30 other countries. If you want to make a difference, start here.
JOB SUMMARY
The CSV Engineer II/III will: (1) write all relevant validation deliverables within the Computer System life cycle (including but not limited to summary reports, validation protocols, validation plans, etc.), (2) participate in on-site CSV activities at multiple locations, and (3) review/generate test scripts, change controls, process improvements, and so on.
CORE DUTIES
- Produce and support adherence to SOPs, perform risk assessment, and complete change controls & validation reports
- Ensure that appropriate cGMP regulations are followed as well as draft, review, and approve local validation efforts
- Document results/non-conformances and execute CAPA
- Assist cross-functional validation with depts. Such as Information Systems, Manufacturing, and QA Engineering
SKILLS & EDUCATION
- 3+ years of relevant experience in automation, engineering, operations, or project management within cGMP environment; 2+ years of recent automation experience
- Familiarity with computer systems in mfg., process, and facilities qualification
- Biotechnology and/or pharmaceutical/medical experience
- Knowledge of recent GMP standards, including 21 CFR Parts 11, 210, 211, and 820; ICH Q7A req.; GAMP (5 preferred, 4 acceptable)
- Excellent written and verbal communication skills
- Ability to work in a fast-paced environment
POTENTIAL BENEFITS
- Health, vision, dental insurance
- Medical plan stipend each pay period
- Paid vacation
- Tuition reimbursement
