Description:
Validation Execution – Draft and implement quality system documentation; author and execute URS, IQ, OQ, PQ protocols per GDP and cGMP.
Equipment & Process Qualification – Support qualification of analytical instruments, automated/manufacturing systems, aseptic process simulations, PPQ, material qualifications, and sterilization cycles.
Regulatory Compliance – Conduct USP <1058> analytical qualifications and 21 CFR Part 11 automation assessments; ensure alignment with SOPs, global standards, and regulatory guidelines.
Cross-Functional Collaboration – Partner with vendors, IT, EH&S, Quality, and other stakeholders to coordinate validation and change control activities.
Expertise & Culture – Strong CQV background; promotes a right-first-time culture while managing multiple priorities in a fast-paced, regulated environment.
Job Type: Contract
Pay: $50.00 - $60.00 per hour
Expected hours: 40 per week

Benefits:

• 401(k)
• Health insurance

Experience:

• Validation: 1 year (Required)
• IQ/OQ/PQ: 1 year (Required)
• Equipment/ Instrument Validation or Qualification: 1 year (Required)

Location:

• Boston, MA (Required)

Ability to Commute:

• Boston, MA (Required)

Work Location: On the roa

Please refer the Job description for details