Lead Equipment Validation Engineer

A pharmaceutical company in the Raleigh, NC area is looking for a Lead Equipment Validation Engineer to join their growing team. The Lead Equipment Validation Engineer is responsible for overseeing the validation of equipment and systems used in pharmaceutical manufacturing. This role ensures that all equipment operates in compliance with regulatory standards and company policies, thereby guaranteeing the safety and efficacy of pharmaceutical products.
Key Responsibilities:
Develop and implement validation plans, protocols, and reports for new and existing equipment, ensuring compliance with regulatory requirements (e.g., FDA, EMA).
Lead the execution of validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Prepare and review validation documentation, including protocols, reports, and standard operating procedures (SOPs).
Conduct risk assessments to identify potential issues with equipment and processes, and develop mitigation strategies.
Supervise and mentor a team of validation engineers and technicians, providing guidance and support to ensure successful project completion.
Identify opportunities for process improvements and implement best practices to enhance validation efficiency and effectiveness.
Work closely with other departments, such as Quality Assurance, Production, and Engineering, to coordinate validation activities and resolve issues.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .

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Required Skills & Experience

Bachelors degree in Engineering, Biotechnology, or a related field. Advanced degree preferred.
5-7 years of experience in equipment validation within the pharmaceutical industry, with at least 2 years in a leadership role.
In-depth knowledge of validation principles and regulatory requirements (e.g., FDA, EMA).
Strong project management and organizational skills.
Ability to lead and mentor a team effectively.
Proficiency in validation software and tools: Kneat

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.