16 days old

Sr Validation Engineer (Pharma)

Kelly Services
Harmans, MD 21077
Sr Validation Engineer (Pharma)

6 months with probable entension


Harmans.MD (Onsite)

The Senior Validation Engineer will work in an FDA regulated clean room environment, this position is responsible for validation of bio process equipment and GMP utilities. We are seeking a candidate with experience in commissioning of a new facility with a hands-on approach to working with others to accomplish goals and objectives.

Key Responsibilities:

Generates operational protocol(s), qualification IQ, OQ, PQ protocols and SOPs for various equipment/systems/processes in the facility.

Project based work will be in 3 main areas: Equipment Qualification, HVAC/Clean Room Qualification, and Temperature Mapping (Kaye Validator and/or AVS)

May also develop Validation Master Plans, Validation Project Plans and Project Schedules as needed.

Oversees the timely completion of all validation documentation, including coordination of contractor activities.

Works closely with Manufacturing, QA/QC and Facilities staff in the execution of validation activities, as applicable.

May interact with internal clients and external vendors on equipment/process requirements.

Support the maintenance of the validation program for facilities and equipment.

Support changes through the provision of necessary validation documentation and change control activities.

Support the regulatory defense of validation protocols and summary reports during audits and internal audits.

Develop and support continuous improvement initiatives for the validation of equipment, facility, utility, and control systems

Provide hands on support to the manufacturing areas as required to assist in problem solving and long-term changes that provide product/process improvements in relation to equipment failures. Collect and analyze data to make data driven recommendations/decisions

Participate in equipment failure investigations

Build and maintain successful cross-functional relationships with internal customers such as Manufacturing, Analytical, Quality and Facilities Engineering

Maintain up to date knowledge of validation requirements, practices, and procedures and instruct other members of the site participating in validation studies

Education & Experience:

B.S. in Engineering or Science discipline

5 or more years of validation experience in a GMP environment

At least 1 year direct experience in the validation of fermenters and autoclaves

Experience with qualifying QC Analytical equipment and Facilities/Utilities is desirable

Working knowledge of Kaye/Amphenol datalogging equipment (Validator, AVS, ValProbe) Physical

**Why Kelly** **** **?**

Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2021-04-02 Expires: 2021-05-03

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Sr Validation Engineer (Pharma)

Kelly Services
Harmans, MD 21077

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