Validation Engineer

About the role

Performance Validation is a 100% employee-owned company that provides Commissioning, Qualification, and Validation services to the life science industries. We have offices in Indiana, Michigan, Illinois, Kansas, Washington, and North Carolina, and support clients throughout the US and overseas.

This is a role for someone who has moved beyond following existing protocols and is ready to build them. You will be responsible for taking systems and equipment through the full commissioning, qualification, and validation lifecycle, from planning and requirements all the way to system acceptance and final summaries. You will be trusted to think critically and develop testing criteria on your own when no relevant protocol exists, to propose and implement solutions as project work evolves, and to work directly with clients, vendors, management, and technical peers to reach consensus on design, testing, and approach. This is also a step into leadership. Level II engineers lead tasks, perform independent validation and commissioning work, and mentor less experienced members of the team.

Responsibilities

• Apply a well-developed knowledge of pharmaceutical industry government regulations, industry standards, and guidelines.
• Demonstrate an understanding of how those regulations and standards are incorporated into client quality systems — including CAPA, Change Control, and Validation.
• Develop commissioning, qualification, and validation documents for a system or piece of equipment from beginning to end — planning and requirements through system acceptance and final summaries.
• Develop and deliver technical presentations to peers and clients.
• Implement the commissioning, qualification, or validation of a system or equipment end to end.
• Independently develop testing criteria in a creative environment where pre-existing protocol does not exist or is not relevant, written logically and clearly enough for others to follow.
• Propose and implement solutions relating to project work.
• Assess and develop the technical aspects of validation and commissioning activities — Master Plans, System Acceptance Final Reports, Risk Assessments, Audits, Gap Analyses, and Remediation Plans.
• Assist in the development or improvement of client quality systems.
• Work directly with clients, vendors, management, and technical peers to gain consensus on design, testing, and approach.
• Mentor less experienced resources. Lead tasks and perform independent validation and commissioning work, applying good project practices throughout.

Requirements

• Educational background: Bachelor’s degree in Engineering, Management, Life Sciences, or another related technical field — or equivalent nuclear navy training.
• Experience: Two or more years of experience in the pharmaceutical or another regulated industry.
• Knowledge: Working knowledge of thermal mapping equipment, computer systems and software, or the principles of a specific scientific or technical discipline.
• Skills: Self-motivated, with a professional demeanor, real enthusiasm, and the ability to work independently. Flexible and dependable, willing to put in the extra time and effort to achieve a goal, and quick to offer help. Confident interaction with clients, contractors, management, and peers, representing the company and division professionally. Excellent oral and written communication, high attention to detail, and the ability to manage several priorities at once.

What We Have To Offer

• Competitive base salary and biannual profit share
• Employee stock ownership program (ESOP) and 401(k) company match
• Medical, vision, and dental coverage
• Disability and life insurance
• Paid vacation and holidays
• Internal and external training opportunities
• Cellphone stipend
• Company-sponsored team building outings
• A collaborative work environment and genuine work/life balance

Additional Information

Position type: Full-time, exempt.

This role reports to a Project Leader.

Location: This is an onsite position based in McPherson, Kansas.

Travel: Availability to travel is required.

Physical requirements: System walk downs require climbing stairs and ladders, maneuvering in and around tight spaces, and lifting moderate weight.

Qualified candidates must be legally authorized to be employed in the United States. Performance Validation does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this position.