Role: QA Validation Engineer
Location: South Shore, MA
A leading biotechnology company focused in drug discovery and development is seeking a QA Validation Engineer to join its new manufacturing facility on the South Shore in Massachusetts. The ideal candidate will have experience in a new facility buildout with a strong engineering background.
- Interact cross-departmentally at all levels with respect to product disposition, quality systems, training, validation, and calibration needs
- Develop and revise Standard Operating Procedures, work instructions, validation plans and protocols, summary reports, and other technical and non-technical documents in support of GMP quality operations
- Review, assess, classify, and approve of Quality Management Systems: including deviations, change controls, CAPAs, and investigations
- Investigate and assist in non-conformances to identify root cause
- Develop corrective and preventive actions (CAPAs)
- Bachelor's Degree with a minimum of 4 years of experience in Biopharmaceutical Operations; degree in engineering field preferred
- Understanding of large-scale manufacturing operations; ideally in a new facility buildout
- Understanding of biologics drug substance purification operations (such as liquid chromatography, TFF, aseptic technique) or a similar complex specialized environment
- An understand of regulatory requirements and their applications in a cGMP environment
- Experience with electronic documentation systems for controlled documents in a cGMP environment
- Strong process systems and equipment validation experience
- Understanding of lean manufacturing methodologies and operational excellence
- Demonstrated ability to manage multiple competing priorities in a fast-paced environment
- Excellent written and oral English language skills
This is an excellent opportunity to join a greenfield project with one of the most disruptive companies in the biotechnology and drug discovery space. Interviews are currently ongoing.
If you are interested in the position of QA Validation Engineer then please forward a copy of your most up to date resume to Connor Dilworth and his team of associates at Real Life Sciences.
Keywords: QA, Quality Assurance, Validation, Engineer, Quality, Systems, QMS, quality systems, calibration, SOPs, standard operating procedures, protocols, document, documentation, cGMP, review, classify, CAPA, change control, investigations, manufacturing, non-conformance, corrective and preventive action, lean manufacturing, engineering
Sthree US is acting as an Employment Business in relation to this vacancy.