Process Validation 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.
CORE DUTIES
- Complete validation on aseptic processes on-site
- Write and execute the technical review of non-conformances; participate in both internal and external audits; implement CAPA as needed
- Determine impact of change control & participate in risk management
QUALIFICATIONS
- 4+ years of experience in a pharmaceutical/biopharmaceutical environment, esp. in Quality
- Experience in equipment qualification, process validation, cleaning validation, and pharmaceutical quality assurance are acceptable
- Validation experience in the areas of: vacuum/steam sterilization, aseptic filling & lyophilization, thermal characterization, heat and mass transfer, and data analysis
- Current knowledge of FDA guidelines, industry standards, and regulatory policies as it relates to validation
SKILLS & EDUCATION
- Strong oral communication, technical writing, and presentation skills
- Current knowledge of industry guidelines, both US and IR FDA/EMA/ISO/
- Familiarity with Microsoft Office Suite
- Ideally, Bachelor's of Science in Chem. Engineering, Biochemistry, Biology, or similar discipline
- 6+ years in the Pharmaceutical industry or work experience in Validation (quality assurance, manufacturing, process development)
- Strong time management skills & multitasking
PHYSICAL REQUIREMENTS
- Comfortable lifting up to 50 pounds on occasion
- Able to stand for extended periods
- Travel to multiple company facilities
- Able to wear appropriate cleanroom apparel and PPE
