SRG, the leader in the Life Sciences human capital industry, is looking for a full-time contract Validation Engineer to operate remotely in the U.S.


SUMMARY DESCRIPTION

This contract position focuses on supporting and overseeing supplier process validations specifically for sterile barrier packaging material manufacturing processes. This role requires expertise in process validation (IQ/OQ/PQ) and a demonstrated ability to guide suppliers in meeting regulatory and company standards.
The candidate will act as the primary liaison between the company and suppliers, ensuring effective communication and execution of process validation requirements, including CTQs verification and validation, risk assessments, and protocol reviews.


ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
To successfully fulfill this role, the candidate will:
* Perform, oversee, and guide supplier process validations (IQ/OQ/PQ) for sterile barrier packaging material manufacturing processes.
* Ensure supplier process validation requirements (CTQs, drawings, specifications, risk levels, and protocols) are communicated, understood, and executed.
* Collaborate with suppliers to review and approve validation documentation, including protocols and reports.
* Provide hands-on support to suppliers during validation activities, ensuring compliance with regulatory standards (FDA, ISO 13485).
* Lead technical discussions with suppliers to address validation challenges and resolve issues.
* Coordinate post-design verification activities, including updates to engineering drawings to reflect CTQs and associated risk levels.
* Deliver progress updates to internal stakeholders, ensuring alignment with program timelines and quality standards.
* Conduct focused process audits, where necessary, to evaluate supplier compliance with validation protocols.

DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill and/or ability required for his position.
Education:
* Degree in Mechanical, Industrial Engineering or Sciences disciplines.
* Skills/Knowledge:
* 8+ years of experience in process validation (IQ/OQ/PQ) within a regulated industry, preferably medical devices or pharmaceuticals.
* Strong understanding of sterile barrier packaging materials and associated manufacturing processes.
* Proficiency in FDA, ISO 13485, ISO 11607, and other applicable regulatory standards.
* Demonstrated ability to work collaboratively with suppliers and cross-functional teams.
* Strong analytical skills and experience using data to drive validation decisions.
* Experience with technical drawings, CTQs, and risk management principles.

TOOLS AND EQUIPMENT USED

Proficiency in general office equipment and software, including data analysis tools and document management systems.

PHYSICAL REQUIREMENTS

Must be able to sit, listen, speak, and type for extended periods. Some supplier site visits may require standing and walking.

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.