Validation Engineer (LEVEL II)

Performance Validation; Raleigh (NC); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

ESOP

401(k) match

Medical insurance

Vision and dental insurance

Paid vacation

Training opportunities

Cellphone stipend

Team building outings

Job summary

Performance Validation is seeking an experienced Validation Engineer/Specialist (Level II) to join our Raleigh, NC team. This role moves beyond following protocols, building them and guiding systems through the full commissioning, qualification, and validation lifecycle.

You will lead tasks, develop testing criteria where none exists, mentor junior staff, and collaborate with clients and vendors to reach consensus on design, testing, and approaches. Onsite role with travel.

Qualifications

• Two or more years of experience in the pharmaceutical or a comparable regulated life science industry.
• Proficiency with Word and Excel.

Responsibilities

• Develop commissioning, qualification, and validation documents for a system from beginning to end.
• Lead tasks and perform independent validation and commissioning work with project teams.
• Collaborate with clients, vendors, management, and peers to reach consensus on design, testing, and approach.

Skills

Self-motivation

Communication

Indep. work

Problem solving

Client interaction

Attention to detail

Education

Bachelor’s degree in Engineering/Life Sciences

Tools

Microsoft Word

Excel

Job description

• Full-time

PERFORMANCE VALIDATION

Validation Engineer / Specialist (Level II)

Raleigh, NC (Onsite)

• Full-time
• Travel required

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 an experienced Validation Engineer/Specialist (Level II) to join our team in Raleigh, North Carolina. This is a role for someone who has moved past following existing protocols and is ready to build them — 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.

Much of the work happens where the answer is not written down yet. 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.

It 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. You will be assigned to one or more project teams and report to a Project Leader, with your divisional home under a Division Director or Manager. At a 100% employee-owned company, the work you do here builds something you own a piece of due to stock ownership and biannual profit share.

What You Will Do

Knowledge

• 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.

Development & Execution

• 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.
• Develop and maintain equipment specification documents.
• Work directly with clients, vendors, management, and technical peers to gain consensus on design, testing, and approach.

Leadership

• Mentor less experienced resources.
• Lead tasks and perform independent validation and commissioning work, applying good project practices throughout.

Requirements You Will Need

Education

• 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 a comparable regulated life science 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

• 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.
• Effective skills in developing, performing, evaluating, and troubleshooting operating systems and controls, or within a specific scientific or technical discipline.
• 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 a Project Leader.

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.