Overview
Seeking a Contractor to be responsible for ensuring that all checkweigher equipment used in pharmaceutical (Solid Dosage & Tablets) manufacturing and packaging processes is validated in compliance with regulatory standards (e.g., FDA, EU GMP, MHRA). This role involves planning, executing, and documenting validation activities to confirm that checkweighers operate accurately, consistently, and reliably within defined specifications.
Key Responsibilities:
- Develop and execute validation protocols (IQ/OQ/PQ) for checkweigher systems.
- Perform risk assessments and gap analyses related to weighing and packaging processes.
- Ensure compliance with cGMP, FDA 21 CFR Part 11, and other applicable regulatory requirements.
- Collaborate with cross-functional teams including Quality Assurance, Engineering, Production, and IT.
- Conduct calibration and performance verification of checkweighers.
- Troubleshoot equipment issues and support root cause investigations.
- Maintain validation documentation including protocols, reports, and change controls.
- Participate in audits and inspections, providing validation evidence as required.
- Train operators and maintenance personnel on validated procedures and equipment use.
- Other duties as needed
Qualifications:
- Bachelor’s degree in Engineering, Life Sciences, or a related field.
- Able to travel for FAT’s (Europe)
- 5+ years of experience in equipment validation within the pharmaceutical or biotech industry.
- Strong understanding of checkweigher technology and packaging line integration.
- Familiarity with regulatory guidelines (FDA, EMA, ICH Q8-Q10).
- Excellent documentation and technical writing skills.
- Proficiency in MS Office and validation software tools.
Preferred Skills:
- Experience with automated packaging systems and serialization.
- Knowledge of statistical analysis and process capability studies.
- Lean Six Sigma or similar process improvement certification.
Job Types: Full-time, Contract, Temporary
Pay: $45.00 - $60.00 per hour
Benefits:
- Referral program
Schedule:
- 8 hour shift
- Monday to Friday
- Overtime
- Weekends as needed
Work Location: In person