Validation Engineer (LEVEL II)

Performance Validation•Raleigh, NC

12d•Onsite

About The Position

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.

Requirements

Bachelor’s degree in Engineering, Management, Life Sciences, or another related technical field — or equivalent Nuclear Navy training.
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.
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.
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.

Responsibilities

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.