Engineer II, Validation
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.
Duties include but are not limited to:
- Executing IQ/OQ/PQ protocols
- Working knowledge of GMP regulations.
- Self-starter with demonstrated analytical and interpersonal skills to allow effective participation in project teams
- Working knowledge of-, and understanding of-, document control/change control practices, FDA Regulations and automated document control/change control systems
- Experience in general quality assurance methods and practices in equipment/ process/ product validation, quality improvement, quality management systems, corrective and preventive action, root cause analysis
- Work with the Validation Team in developing and implementing equipment and process validation protocols to ensure compliance to applicable regulatory requirements, internal company standards and industry practices
- Assist in the development/execution of equipment, process, and shipper qualification activities
- Support QA in client audits
- Develop client-specific/custom equipment qualification templates
Validation Engineer Essential Duties and Responsibilities:
- Develop, write and execute validation protocols (IQ/OQ/PPQ, etc.), for equipment, systems, products and processes
- Work in self-directed manner and must be able to work on SOPs, Equipment Specifications and other controlled documentation as required
- Ability to work effectively under time constraints within a team 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 Protocols, SOPs, forms, records to meet cGMPs and regulatory requirements.
- Ensure timely test completion and result reporting.
- Knowledge of conducting temperature mapping studies, including the operation of Kaye/Amphenol Data loggers or equivalent preferred.
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.
- A minimum of a BS degree in Engineering or Science or similar field is required.
- Bachelor of Science Degree with 2-4 years related work experience in a GMP environment
- Position requires or industry experience in cGMPs. Prefer hands-on industry experience in cGMP/Biotech/Biopharmaceutical/FDA regulated industries.
- Working knowledge of regulatory requirements in the pharmaceutical industry.
- Knowledge of quality systems such as Change Control; CAPA; Deviations
- 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.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.