Equipment Validation Associate

Highly Competitive Salary
  1. Permanent
  2. Analytical Chemistry, Biochemistry, Biological Sciences
  3. United States
Lexington, USA
Posting date: 09 Mar 2021

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.

Job Responsibilities:

  • 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.