Senior Validation Engineer

About Us

Performance Validation (PV) has been providing Commissioning, Qualification, and Validation services to the life science industries for over 30 years. We are a 100% employee-owned company with teams in Indiana, Michigan, Illinois, Kansas, Washington, and North Carolina, and we support clients throughout the US and overseas. As an employer, PV is committed to providing growth opportunities through professional development, implementation of new services, and cultivation of new geographical areas.

About the role

This is the level where your technical judgment becomes the deliverable. Clients will ask you what the validation approach should be, and you will answer with consulting recommendations grounded in deep knowledge of industry standards, solving the complex technical problems that do not have a clean answer. You will work with one or more local or regional customers within your core area of expertise, in a team or independently, meeting defined objectives against an established timeline. Much of this happens in a creative environment where there is no template and no standard form. You will write the deliverable, raise the quality bar through peer review, and help others develop written materials that hold up. It is also a leadership role in the fuller sense.

Level III engineers provide management and technical leadership across validation, engineering, compliance, and scientific activities, lead small project teams or independent operations on time and within budget, and mentor less experienced members of the team. You will also contribute to business development in an ongoing way, developing leads and repeat business through your performance, professional activities, and networking. At a 100% employee-owned company, that is not someone else’s revenue. The work you do here builds something you own a piece of through stock ownership and biannual profit share.

This position reports directly to the Site Manager and you will be assigned to one or more project teams headed by a Project Leader.

What You Will Do

This role carries all of the responsibilities of a Level II Validation Engineer/Specialist, plus the following.

• Knowledge
  • Provide consulting recommendations to clients based on extensive knowledge and application of industry standards.
  • Apply broad knowledge of industry requirements, complete challenging technical work, and provide effective solutions to complex technical issues.
  • Attain and maintain proficiency within a given technical specialty.
  • Contribute to the success of project teams by providing technical expertise.
• Development & Execution
  • Write and develop deliverables in a creative environment where no template or standard form exists.
  • Demonstrate high quality of deliverables and work, proficiency in peer review, and strong technical writing skills.
  • Assist others in developing written materials in accordance with existing requirements.
• Leadership
  • Provide management or technical leadership on a variety of validation, engineering, compliance, scientific, and related activities.
  • Lead small project teams or independent operations effectively, on time and within budget, communicating project status and other critical project information clearly.
  • Understand and apply competency in PV’s project management philosophy.
  • Contribute meaningfully to business development on an ongoing basis, including developing leads and repeat business through performance, professional activities, and networking.
  • Stay conversant with the full range of services Performance Validation provides, and discuss them at a general level with clients.
  • Mentor less experienced resources.

Requirements

• Education
  • Bachelor’s degree in Engineering, Management, Life Sciences, or another related technical field, or equivalent Nuclear Navy training.
• Experience
  • Five or more years of experience in the pharmaceutical or another regulated industry.
  • Depending on assignment, working knowledge of thermal mapping equipment, computer systems and software, or the principles of a specific scientific or technical discipline.
  • Proficiency with Microsoft Word and Excel.

Skills

• Proven client relations skills, and the credibility to be trusted with a consulting recommendation.
• The ability to work effectively in an independent manner.
• Respected by peers, with the ability to influence within both technical and management disciplines.
• Effective skills for developing, performing, evaluating, and troubleshooting within a specific scientific or technical discipline.
• Flexible and dependable, willing to put in the extra time and effort to achieve a goal, and quick to offer help.
• Excellent oral and written communication, high attention to detail, and the ability to manage several priorities at once.

Benefits

• 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