Johnson Service Group, a nationally award-winning staffing firm, has an immediate opportunity for a cGMP Validation Engineer – Biotech & Life Sciences in Carlsbad, CA.

Direct Hire | Onsite | Salary $108K - $116K based on skills, education, experience, and other relevant qualifications.

Summary: 
This role ensures facilities, utilities, equipment, and processes are properly validated and maintained in compliance with cGMP standards. Responsibilities include authoring, executing, reviewing, and approving validation protocols, reports, and related documentation. The position works cross-functionally to define critical process parameters and develop test plans confirming equipment and process suitability.

Ideal candidates have experience in aseptic drug product and/or life science manufacturing, strong knowledge of validation principles, and proficiency in computerized systems validation (CSV).

Responsibilities and Duties Develop, author, and execute validation protocols (IQ/OQ/PQ), reports, and supporting documentation in compliance with regulatory and internal quality standards. Author and review validation protocols and reports, and provide technical input for validation deviations, investigations, and change control assessments. Ensure that facilities, utilities, equipment, and processes are qualified and maintained in a validated state. Assume responsibility for assigned tasks related to equipment, facility, utility, and process qualifications and validations, ensuring compliance with applicable SOPs, regulatory requirements, and safety standards. Experience developing and executing equipment impact assessments and validation protocols and reports for production facilities and equipment in a pharmaceutical cGMP regulated environment. Collaborate cross-functionally with other departments and external clients to define critical process parameters and acceptance criteria. Coordinate and collaborate with cross-functional teams to align validation and compliance efforts, ensuring all qualification and validation activities meet established requirements. Experience and expertise in communication exchanges with internal or external customers. Support validation activities necessary to achieve the organization's mission and contribute to the execution of strategic growth initiatives. Operate effectively both independently and as part of a collaborative team environment. Proven success in a validation role in life science and/or pharmaceutical manufacturing environment. High intelligence and problem-solving skills. Excellent oral and written communication skills and listening skills. Requirements and Qualifications A bachelor's degree is preferred; and five (5) or more years of progressive, relevant cGMP validation experience is required. Time and project management skills with the ability to multi-task are essential. High level of personal and professional integrity and trustworthiness with a strong work ethic and the ability to work independently with minimal direction. Experience in a growth-oriented, cGMP contract manufacturing organization with a focus on compliant execution of business is preferred. #D800
** Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.