At Fisher BioServices, we specialize in the management of critical biological materials in support for the advancement of cell therapy, high value biologics, and population-based public health research. We provide customized end-to-end chain of custody solutions for our large pharmaceutical clients and partners in academia and government, ensuring the integrity and efficacy of their valued material from the manufacturer to the bedside. Fisher BioServices is a brand of Thermo Fisher Scientific, the world leader in serving science, and member of the BioPharma Services Division. To learn more please visit www.fisherbioservices.com.
Position Summary: Lead the day-to-day operations of the Validation Team. Duties include but are not limited to: supervising/training of validation personnel; prioritizing/coordinating validation/calibration efforts.; assisting in the development/execution of equipment, process, and shipper qualification activities; supporting QA in client audits; assisting Sales & Marketing in promoting our services; training Validations and Operations personnel, as needed; developing equipment qualification templates; performing annual reviews and preparing annual budgets; implementing a Technical Training Program.
Validation Lead Essential Duties and Responsibilities:
- Prioritize and coordinate the daily activities of the Validation Engineers and Technicians/Validation contractors.
- Knowledge of conducting temperature mapping studies, including the operation of Kaye/Amphenol Data loggers or equivalent preferred.
- Develop validation protocols to support the qualification/validation of equipment, processes and facilities (e.g.IQ, OQ and PQ protocols, Operational SOPs Change Controls, User/Functional/Design Specifications, etc).
- Generate and execute all Validation protocols (IQ/OQ/PQ) of all site equipment including production equipment, utilities as applicable) and other related systems in a FDA regulated environment.
- Initiate and execute Corrective and Preventative Actions (CAPA) as required and / or contributing to/supporting CAPAs as needed to resolve deviations resulting from qualification studies
- Update and maintain Validation Master Plans, Validation Plans, Validation Protocols, Qualification Program SOPs, forms, records to meet cGMPs and federal regulatory requirements.
- Ensure appropriate staff appointment and training.
- Experience/understanding of cGMP, ICH Q9 Quality Risk Management is desired.
- Preparation of project plans, budgets and special assignments. Develop and implements strategic and tactical plans to accomplish business objectives; prepares project budgets and manages to plan.
Basic Minimum Qualifications: The qualifications listed below are representative of knowledge, skill and/or ability. To perform this job successfully, an individual must be able to complete each essential duty.
- Requires ability to communicate effectively verbally and in written form.
- Ability to prepare reports using Excel; knowledge of Windows, Word and Access preferred.
- Knowledge of universal Precautions, general laboratory and quality assurance/control preferred.
- Valid driver’s license and good driving record if required to travel to other locations.
- Bachelor of Science Degree with a minimum of 5 years related work experience including a minimum of 3 years of supervisory experience. Advanced degree strongly preferred.
- Position requires advanced training and/or industry experience in cGMPs. Prefer hands-on industry experience in cGMP/Biotech/Biopharmaceutical/FDA regulated industries.
- Strong working knowledge of regulatory requirements and ISO requirements in the parenteral pharmaceutical industry.
- Excellent verbal and written communication skills required
- Experience with and knowledge of related quality systems such as Change Control; CAPA (including Deviations/OOSs); Training; and Document Control is required.
- Experience with validation aspects of facility start-up, redesign/retrofit, and expansion is desired.
Coordinate and prioritize all activities of the Validation Team.
- Exempt. Required to travel locally and for off-site qualification support projects
Work Conditions/Physical Requirements:
- Ability to work in a cold environment with exposure to dry ice, liquid nitrogen cryogenics, hazardous and infectious agents, marked changes in temperature.
- Must use personal protective equipment and adhere to safety protocols.
- Must be able to lift and carry up to 50 lbs, and push up to 70 lbs.
- Must be able to process and handle materials frozen on dry ice (-78°C) or liquid nitrogen (-195°C) for up to 6 hours per day.
- Must be able to work in walk-in freezers or refrigerators periodically for up to 5 hour per day.
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