Validation Engineer 2

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Your Role:

In this role you are responsible for establishing, justifying, executing, and maintaining validated cleaning processes for equipment and processes supporting existing and new clients. The position ensures that cleaning validation activities comply with applicable cGMP, FDA, and EU regulations (including 21 CFR 210 & 211, 21 CFR Part 11, EU GMPs, ICH Q7, Q8, Q9, Q10), with specific focus on control of cleaning agents and minimization of cross-batch contamination risk.

Responsibilities include but are not limited to:

• Establish, justify, and validate cleaning processes for new/modified equipment and clients, ensuring full compliance with FDA and internal regulatory standards.
• Author and execute IQ/OQ/PQ and CV-specific protocols, managing 3-5 annual requalification for processes, equipment, and utilities.
• Serve as the site SME for cleaning-related deviations, CAPAs, and change controls, leading investigations and cleanability studies.
• Author, revise, and deliver training on cleaning SOPs to Manufacturing operators to ensure qualification and documentation compliance.
• Develop cleaning validation strategies, including worst-case assessments and residue limits, to control cross-batch contamination risks.
• Apply statistical tools for trend analysis and continued process verification to monitor and maintain cleaning performance.
• Perform technical peer reviews of protocols, reports, and risk assessments while supporting Annual Product Quality Reviews (APQRs).
• Provide cleanability requirements for new system designs and demonstrate proficiency in site electronic quality management systems (eQMS).

Who You Are:

Minimum Qualifications:

• PhD in Biology, Chemistry, Chemical Engineering, Physical Engineering or other Life Science or Engineering discipline and 2+ years of validation experience in a regulated pharmaceutical or biopharmaceutical environment.

OR

• Master's Degree in Biology, Chemistry, Chemical Engineering, Physical Engineering or other Life Science or Engineering discipline and 3+ years of validation experience in a regulated pharmaceutical or biopharmaceutical environment.

OR

• Bachelor's Degree in Biology, Chemistry, Chemical Engineering, Physical Engineering or other Life Science or Engineering discipline and 5+ years of validation experience in a regulated pharmaceutical or biopharmaceutical environment.
• 1+ years of experience in an aseptic pharmaceutical environment with exposure to aseptic bulk formulation, aseptic filling, and packaging processes.

Preferred Qualifications:

• Prior experience in the qualification and validation of sterile facility equipment, such as sterilization technologies (Steam, Dry Heat, VHP, etc.), temperature-mapped chambers, aseptic equipment (washers, tunnels, cappers, RABS, isolators, etc.), pharmaceutical-grade utilities, process validation, and cleaning validation.
• Experience in validation activities and the use of validation test equipment (e.g., Kaye Validator, Val Probe, PLC-based systems, temperature/pressure standards).
• Strong verbal and written communication skills.
• Self-motivated, highly organized, and conscientious, capable of working independently and in cross-functional teams in technically and mentally demanding situations.

Pay Range for this position: $67,300 - $100,900 / year

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.

RSREMD

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!