Senior Validation Engineer

Performance Validation; Raleigh (NC); Sur place; USD 110 000 - 170 000; Plein temps

Avantages offerts par ce poste

Competitive base salary

ESOP

401(k) company match

Medical, vision, and dental coverage

Disability and life insurance

Paid vacation and holidays

Training opportunities

Cellphone stipend

Team-building outings

Work/life balance

Résumé du poste

Performance Validation in Raleigh, NC seeks a Senior Validation Engineer/Specialist (Level III) to provide expert validation guidance, lead projects, and mentor team members. You will shape validation strategy, write deliverables, and contribute to business development while managing client relationships.

The role requires demonstrated leadership, deep regulatory knowledge, and the ability to work independently on time and within budget in a dynamic, employee-owned environment.

Qualifications

• Five+ years in pharmaceutical or a regulated industry.
• Experience with thermal mapping equipment, software, or related discipline.
• Proficiency with MS Word and Excel.

Responsabilités

• Provide consulting recommendations based on industry standards.
• Lead validation, engineering, and compliance activities.
• Mentor less experienced team members and lead project teams.

Connaissances

Client relations

Independence

Influence

Troubleshooting

Written communication

Time management

Formation

Bachelor’s degree in Engineering or related field

Nuclear Navy training (equivalent)

Outils

MS Word

MS Excel

Description du poste

About Us

Here at Performance Validation (PV) we have 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 to our employees through professional development, implementation of new services, and cultivation of new geographical areas.

About the Job

Performance Validation is seeking a Senior Validation Engineer/Specialist (Level III) to join our team in Raleigh, North Carolina. 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 You Will Need

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 You Will Bring

• 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.

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

Please note that the salary range provided is a good faith estimate on the applicable range. The final salary offer will be determined after considering relevant factors, including a candidate’s qualifications and experience, where appropriate.

Position type: Full-time, exempt. This role reports to the Site Manager.

Location: This is an onsite position based in Raleigh, North Carolina.

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.

Performance Validation is an Equal Opportunity Employer

We believe in the dignity, value, and potential of every individual. Performance Validation provides equal employment opportunities to all employees and applicants and makes employment decisions based on qualifications, merit, and business needs.

We do not discriminate on the basis of race, color, religion, creed, national origin, citizenship status, age, sex, pregnancy, sexual orientation, gender identity, marital status, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law. Performance Validation is committed to maintaining a workplace free from discrimination, harassment, and retaliation. We prohibit conduct that demeans, intimidates, threatens, or creates an offensive work environment based on any protected characteristic. Reasonable accommodations are available for qualified individuals with disabilities throughout the application and employment process.