Join our team at Genesis, where we have the privilege of contributing to worldwide health through the design and construction of facilities where science is conducted and life-saving drugs are manufactured. This is a tremendous opportunity for a dedicated individual who wants to contribute to our client’s success, as well as our impressive growth.

Genesis is dedicated to supporting professional development in a welcoming work environment. Our collaborative culture ensures that our clients benefit from top-tier work across our entire range of professional offerings.

At Genesis, we believe that hard work and achievement are integral to a balanced and rewarding life. As our single most valuable asset, we make sure our employees know that we appreciate them. At Genesis, you will find people from many different backgrounds and with very different interests all working together to achieve a common goal.

Minimum Qualifications:

  • Bachelor’s degree in Engineering, Science or equivalent technical discipline.

  • 3+ years experience in validation/verification services, in a regulated manufacturing environment, preferably in QA within the biotechnology, pharmaceutical, medical device industries.

  • Two or more years of direct equipment, systems or utilities validation/verification experience

  • Ability to read and interpret Piping and Instrument Diagrams (P&IDs) and electrical diagrams

  • Travel Required (Domestic/International)

What You Will Do:

Candidate will be responsible for validation and verification studies (FAT, SAT, IOQ, PQ) for cleaning, shipping, equipment, systems, utilities, and processes and ensure compliance with the relevant regulatory (local, state and federal) agencies. Writes, approves and executes protocols, resolves deviations/discrepancies, reviews and analyzes study data, writes and approves summary reports. Writes, reviews and revises a variety of installation, operation and performance qualification/verification related documents, including the following: SOPs, validation/verification master plans, guidelines and execution plans, automation, engineering design, commissioning, qualification or other technical documents, user requirement specifications (URS), basis of design documents (BOD), functional requirement specifications (FRS), detailed design specifications (DDS), factory acceptance test documents (FAT), verification protocols, and/or commissioning test procedures (CTP).

 


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