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Validation Engineer

Company: Genesis AEC
Location: Plymouth Meeting
Posted on: May 28, 2023

Job Description:

Validation Engineer
Do you have a meticulous eye for detail? Are you looking for a career that will leverage this and your outstanding ability to build meaningful relationships?
If so, we are looking for you to join our exceptional team as our Validation Engineer!
We're Genesis AEC - an award-winning architecture, engineering, construction management, and CQV firm and a leader in the life sciences industry. Ranked #5 in Pharmaceutical Design by ENR magazine, we're designing and constructing facilities that advance worldwide health. We're proud to contribute to our clients' success, earning honors that include a 2021 ISPE Facility of the Year (FOYA) award and an ENR Mid-Atlantic's Best Manufacturing Project award for our work at the National Institutes of Health.
Our culture is based on inclusion, one where all identities, backgrounds, and perspectives are embraced. When you're on our team, you'll find you are supported, challenged, and encouraged to grow - with opportunities, training, and a work-life balance to help you succeed.
What You Will Do
You will be responsible to author and execute the start-up, commissioning, and validation of new or modified equipment, train with senior validation engineers and project managers to create protocols and reports. The Validation Engineer will write and execute protocols, such as Commissioning Test Plans (CTPs), Installation, Operational and Performance Qualifications (IOPQs) and Utilities Qualification. Projects and duties will be completed in compliance with applicable cGMP, FDA, and all other regulatory agencies standards in compliance with client site's policies and department, local procedures and regulatory expectations.
- Develop qualifications and retirement documentation.
- Conducts field execution of commissioning validation deliverables, resolve any deviations, and author reports.
- Work within cross-functional teams; communicates progress effectively to other team members and validation management.
- Ensure process and project documentation is accurate and updated.
- Maintains safe working environment
- Ensures that all activities are in compliance with regulations applicable to the project.
- Completes assigned projects in timely manner.
- Maintains and improves job knowledge.
- Perform other special projects and duties as assigned by department management
Minimum Qualifications
Successful candidates will have hands on experience with laboratory equipment such as centrifuges, pumps, tube sealers and tube welders, autoclaves, parts washers and temperature mapping equipment (Kaye Validator 2000, Kaye AVS, or similar). You must be willing to spend most of your time in the field and be available for long-term projects. You will be mentored by a senior level engineer and eventually take on management of a project or become a project lead.
- 1 to 5 years of experience in Pharmaceutical industries.
- Bachelor degree in a Science field required but Mechanical Engineering or Chemical Engineering is preferred.
- Demonstrated understanding reviewing/writing technical documents, risk assessment reports, commissioning/validation documents, IOQ/PQ protocols and final reports.
- Proficiency in MS Office, and Adobe Professional
- Strong oral and written communication skills
- Ability to work well under pressure, prioritize multiple projects and adjust work against tight deadlines
Preferred Qualifications
- Experience with Pharmaceutical, Biotech, Life Science and Laboratory industries
- Design experience
- Technical writing

  • Our collaborative and positive culture sets us apart

  • We offer schedule flexibility*, including 9-hour days Monday-Thursday and 4-hour Fridays, all year long; daily hours that work with your commuting or personal obligations; and a hybrid in-office and work from home balanced work week. *For field-based personnel, flexible scheduling may be subject to client/project site requirements.

  • Comprehensive medical, dental, vision and RX insurance plans, with two-thirds of your premiums and deductible paid!

  • Competitive 401k match program

  • Generous paid time off

  • Thought leadership opportunities, including a $1,000 award for presenting or publishing your technical expertise!

  • Competitive company-paid training opportunities

  • A 5% salary increase for earning your professional license!

  • Endless opportunities to grow your career

  • And so much more!

    Are you ready to unlock your potential with us? With your passion and our vision, there's no limit to what you can accomplish here! Submit your resume today for immediate consideration.

Keywords: Genesis AEC, Philadelphia , Validation Engineer, Engineering , Plymouth Meeting, Pennsylvania

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