Equipment Validation Engineer(Contract) 22222, Boston

Equipment Validation Engineer(Contract) 22222

10 Days Old

The CQV Engineer is responsible for supporting and executing Commissioning, Qualification, Validation, and Requalification activities across GMP-regulated facilities. This role involves the development and execution of validation protocols, cross-functional collaboration, and adherence to cGMP, company standards, and regulatory guidelines. The ideal candidate will have hands-on experience in protocol development and execution within a pharmaceutical or biotech environment and demonstrate the ability to work independently while managing multiple validation tasks.

Key Responsibilities:

Develop and execute qualification and validation protocols, including IOQ and PQ documentation.
Ensure validation activities comply with internal SOPs, global standards, and current Good Manufacturing Practices (cGMP).
Coordinate scheduling and execution of test plans with internal teams and external vendors.
Collaborate with cross-functional departments such as Engineering, Facilities Operations, QA, GIS, EH&S, Global Security, and PMO.
Support safe execution of validation activities in alignment with operational and construction timelines.
Promote a "right-the-first-time" culture and maintain documentation accuracy across all validation deliverables.
Maintain up-to-date compliance with assigned training and documentation requirements.
Support the reputation and integration of the Engineering team by fostering effective cross-functional partnerships.

Requirements

Required Qualifications:

Bachelor's degree in Engineering (Chemical, Biomedical, Industrial, Biotechnology) or related scientific discipline.
2-4 years of experience in Commissioning, Qualification, and Validation (CQV) within a GMP-regulated industry.
Experience developing and executing qualification protocols in a regulated environment.
Familiarity with Kaye Validator, data loggers, and temperature mapping equipment.
Understanding of industry regulations and standards including GMP, ISO, GAMP, and ANSI.
Demonstrated ability to adapt to change, solve technical problems, and troubleshoot equipment/process issues.
Strong written and verbal communication skills.
Self-motivated with the ability to work independently and manage multiple priorities.

Benefits

CONTRACT

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Location:: Boston

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