CQV Engineer

Required Qualifications Bachelor's degree in Engineering, Life Sciences, Computer Science, or a related technical field, or equivalent experience. Minimum 3 years of hands-on experience developing and executing validation protocols using the Kneat platform .

Job Title: CQV Engineer

Location: Plainville, MA

Employment Type: Contract (6 Months)

Job Responsibilities

• Develop, review, and execute Commissioning, Qualification, and Validation (CQV) protocols using the Kneat platform.

• Prepare and execute IQ/OQ/PQ protocols, reports, discrepancy investigations, and qualification documentation.

• Support validation of laboratory and analytical equipment, including Computer System Validation (CSV).

• Collaborate with Engineering, Manufacturing, QA, and QC teams to ensure GMP compliance.

• Support change control, impact assessments, deviation management, and validation planning.

• Ensure documentation complies with Good Documentation Practices (GDP) and current GMP requirements.

• Independently manage qualification activities, project timelines, and deliverables.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, Computer Science, or a related technical field, or equivalent experience.

• Minimum 3 years of hands-on experience developing and executing validation protocols using the Kneat platform.

• Minimum 3 years of CQV experience in pharmaceutical, biotechnology, or medical device environments.

• Experience supporting CSV activities for analytical laboratory equipment and computerized laboratory systems.

• Strong understanding of GMP, cGMP, GDP, data integrity, and validation lifecycle principles.

• Knowledge of IQ/OQ/PQ, change control, deviation management, CAPA, and risk assessments.

• Familiarity with FDA, EMA, and GAMP 5 guidelines.

• Strong technical writing, communication, and project management skills.

Pay Scale

Anticipated hourly pay range $48 $54 per hour on W-2.

Benefits

Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:

Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO): No PTO other than that required by applicable state and local laws.