Validation Engineer II (Assay)

Overview

Cook MyoSite, Inc., part of the Cook Group, Inc. family of companies, is on a mission to make regenerative medicine a part of everyday medicine. We’re investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply.

The Validation Engineer II (Assay) at Cook MyoSite, Inc. is responsible for the successful planning, design, execution and control of the validation status of assays as well as the associated instruments. This person will be responsible for authoring and supervising execution of assay validation projects for a cell therapy and biopharmaceutical manufacturing company.

Responsibilities

1. Provide technical assistance regarding the validation requirements for instruments and assays including design reviews, document generation (URS, DQ/IQ/OQ/PQ protocols, SOPs, and final reports), and protocol execution.
2. Plan, author, and lead validation of instruments and assays.
3. Oversee/manage execution of assay validation protocols by Quality Control, Development and appropriate personnel.
4. Problem solve and implement solutions to ensure operation of assays in a validated state.
5. Write, implement and review SOPs and train employees according to SOPs and GMP requirements.
6. Perform laboratory work as needed to support assay validation protocols.
7. Prepare and maintain accurate and complete technical documentation, such as lab notebooks and validation protocols.
8. Trend the validated state of qualified instruments.
9. Prepare turn over packages (TOP) to transfer systems in a validated state to system owners.
10. Must maintain company quality and safety standards. Become familiar with SOPs, applicable Quality Standard, Work Instructions, functional doc and operational guidance.

Qualifications

1. Undergraduate degree in Engineering or any Life Sciences.
2. Minimum 5 years of experience in a regulated industry (pharma or biotech).
3. 2-4 years' experience in designing, authoring, and leading analytical instrument qualifications and assay validations, or other relevant validation experience.
4. Cell-based assay development/validation experience preferred.
5. Minimum of 1 years’ experience in Quality Control.
6. Robust understanding of cGMP and validation systems and processes; experience with USP <1058> and ISPE validation processes a plus.
7. Working knowledge of Project and Risk Management.
8. Working knowledge of engineering documentation required for cGMP equipment (i.e URS, IQ, OQ, PQ, DQ).
9. Proficient knowledge of Microsoft Office software, and other general office equipment.
10. Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing.
11. Proficiency or comfort level working with material of a highly technical or scientific nature.
12. Ability to learn and support new systems and applications, and the ability to provide technical training to end users.

Physical Requirements:

1. Laboratory Setting (Non-Production): General office, warehouse and laboratory setting with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II.
2. Ability to conduct and hear ordinary conversation and telephone communication.
3. Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required.
4. Ability to work under specific time constraints.
5. Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.
6. Visual and manual acuity for working with computers and equipment.
7. Ability to spend majority of day standing in laboratory setting or sitting in biological safety hood setting.
8. Physically capable of standing, walking, stooping, kneeling, crouching, climbing steps and ladders, reaching, twisting and bending on occasion with or without reasonable accommodations.
9. Must be able to lift/push/pull up to 50 pounds on an occasional basis with or without reasonable accommodations.
10. Must be capable of performing PPE gowning procedures on a frequent basis to enter BioSafety Level II including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and facial mask (if required) on a regular basis.
11. Must be able to extend arms outright for extended periods of time, periodically at intervals for up to 3 hours at a time.