Validation Engineer I PC 846
About The Position
Your Role: This position is responsible for adhering to the validation program, maintaining and assuring compliance with the Validation Master Plan, lifecycle process and, regulatory requirements and Site policies. Essential Duties and Responsibilities: Draft and execute validation protocols (IQ, OQ, PQ, EMPQ, Aseptic Process Qualifications, etc.). Author validation and technical protocols, reports and develops project plans. Support validation and technical assessments for quality impact and participate on quality investigation teams. Monitor maintenance of the validated state of basic and some complex equipment and utilities via Validation Master Lists and processes. Act as an SME in client and regulatory audits, addresses audit findings, CAPAs and deviations. Generate, review, and assess validation final reports and addresses gaps as required. Conduct risk assessment, create FMEAs and other documents to justify the validation approach being taken Participate in change control evaluations and provides feedback on validation and/or calibration status impact. Perform routine gap analysis of the site’s Validation and Calibration Programs to correct gaps as required. Manage and coordinate validation and calibration contractors to ensure the preservation of the equipment, process and facility’s validated state. Create and revise SOPs related to the site’s Validation and Calibration programs to maintain their accuracy and ensure best practices are being followed. Oversee computerized system validations. Responsible for all GMP documentation related to validation and calibration at the site activities.
Requirements
- Bachelor's degree in engineering (Mechanical, Electrical, Chemical) or a Scientific discipline (required)
- 0-2 years’ experience related to validation and/or engineering in the pharmaceutical and/or biotech industry.
- Working knowledge of regulations (cGMP-FDA 21CFR 210/211, 600 and/or part 11 Eudralex Volume 4).
- Microsoft office software
- Microsoft Project
Nice To Haves
- Experience in the validation, commissioning and qualification or equipment systems is a plus.
- Cleaning Validation experience is a plus
- Visio is a plus
Responsibilities
- Draft and execute validation protocols (IQ, OQ, PQ, EMPQ, Aseptic Process Qualifications, etc.)
- Author validation and technical protocols, reports and develops project plans.
- Support validation and technical assessments for quality impact and participate on quality investigation teams.
- Monitor maintenance of the validated state of basic and some complex equipment and utilities via Validation Master Lists and processes.
- Act as an SME in client and regulatory audits, addresses audit findings, CAPAs and deviations.
- Generate, review, and assess validation final reports and addresses gaps as required.
- Conduct risk assessment, create FMEAs and other documents to justify the validation approach being taken
- Participate in change control evaluations and provides feedback on validation and/or calibration status impact.
- Perform routine gap analysis of the site’s Validation and Calibration Programs to correct gaps as required.
- Manage and coordinate validation and calibration contractors to ensure the preservation of the equipment, process and facility’s validated state.
- Create and revise SOPs related to the site’s Validation and Calibration programs to maintain their accuracy and ensure best practices are being followed.
- Oversee computerized system validations.
- Responsible for all GMP documentation related to validation and calibration at the site activities.
Benefits
- In addition to your salary, the Company offers a comprehensive benefits package, including health, vision, and dental insurance, as well as a 401(k) plan.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
1,001-5,000 employees
