Validation Engineer

Senior Talent Acquisition Specialist at United Consulting Hub, INC | Recruitment-to-Recruitment

Job Title: Validation Engineer

Experience: 3+ Years

Location: Boston / Cambridge, Massachusetts Onsite

Industry: Pharma / Biotech / Medical Devices / Manufacturing

We are seeking a detail‑oriented Validation Engineer with around 3 years of hands‑on experience to support validation activities across equipment, processes, utilities, cleaning, and computerized systems in a GMP‑regulated environment
. The role involves executing validation protocols, supporting compliance activities, and ensuring adherence to FDA, cGMP, and global regulatory requirements.

• Execute and support IQ, OQ, and PQ activities for manufacturing equipment, utilities, and laboratory instruments.
• Prepare, review, and execute validation protocols, reports, and deviation summaries
  .
• Support process validation, cleaning validation, and equipment qualification activities.
• Assist in CSV (Computer System Validation) including risk assessments, user requirements, and test scripts.
• Ensure validation documentation complies with cGMP, FDA, 21 CFR Part 11, EU GMP, and ICH guidelines
  .
• Coordinate with Engineering, Manufacturing, QC, QA, and Automation teams during validation execution.
• Perform risk assessments (FMEA) and support change control, CAPA, and deviation investigations.
• Support internal audits, client audits, and regulatory inspections
  .
• Maintain validation traceability matrices and controlled documentation.
• Ensure timely completion of validation deliverables per project timelines.

• Bachelor’s degree in Engineering, Life Sciences, or related field
  .
• 3+ years of experience in validation within regulated GMP environments
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• Strong hands‑on experience with IQ/OQ/PQ documentation and execution
  .
• Good understanding of cGMP, FDA regulations, and validation life cycle
  .
• Experience with manufacturing equipment, utilities (HVAC, Water Systems), or lab instruments
  .
• Familiarity with documentation control systems and SOPs
  .

• Experience in pharmaceutical or biotech manufacturing facilities
  .
• Exposure to cleaning validation and process validation
  .
• Knowledge of CSV tools and electronic systems (LIMS, MES, ERP).
• Experience with calibration, deviation management, and change control
  .
• Excellent documentation and communication skills.

• GMP, FDA, 21 CFR Part 11
• SOPs, Change Control, CAPA
• Equipment Qualification & Utilities Validation

• Strong attention to detail
• Ability to work cross‑functionally
• Good analytical and problem‑solving skills

Mid‑Senior level

Contract

Engineering, Product Management, and Manufacturing

Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Biotechnology Research