Equipment Validation Associate
Proclinical is currently recruiting for Equipment Validation Associate with a pharmaceutical company located in Lexington, MA. The successful candidate demonstrates expert understanding of executing equipment validation activities in a Quality Control Laboratory. Responsible for identifying, alerting and proposing solutions to issues on instruments and or test executions; aids and implements recommended solutions and or corrective actions of OOT/OOS findings according to cGMP standards. Ability to troubleshoot analytical instrumentation such as HPLCs/UPLCs. Working knowledge of cGMP's and their application to Quality Control. Demonstrates strong attention to detail and appropriate safety consciousness.
- Writes and develops equipment validation and qualification protocols.
- Review of validation protocol data.
- Perform IQ/OQ/PQ
Skills and Requirements:
- BS and/or MS degree in chemistry, biochemistry, cell biology and/or molecular biology discipline
- At least 6 years' work experience in a GMP environment
- Background in equipment validations, analytical support of manufacturing campaigns, quality control, and method transfer
- Background in methodologies supporting both biologics and small molecules
- Direct experience in authoring and review of SOPs, assay qualification protocols and reports
- Strong knowledge of cGMP/ICH/FDA/EU regulations
If you are having difficulty in applying or if you have any questions, please contact Sarah Beshara at 267-477-3355.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.