Logistics:

- 6 month project with potential for extension 

- Remote work may be considered after the initial on-site period.

Overview:

Our client is a clinical-stage biopharmaceutical company specializing in T cell-based therapeutic products for cancer and inflammatory & immunological diseases. With a state-of-the-art manufacturing facility in Maryland producing clinical-grade materials, they are at the forefront of innovation in the biopharmaceutical industry.

We are seeking a Validation Lead to oversee and manage the VMP for their manufacturing facility.

Scope & Responsibilities:

- Lead and manage the Validation Master Plan (VMP), ensuring comprehensive coverage of Commissioning, Qualification, and Validation (CQV), Computer System Validation CSV, and EMPQ.

- Collaborate closely with site facility and operations teams to ensure strict compliance with the VMP activities.

- Conduct a thorough evaluation of the current VMP status, identifying gaps, proposing mitigation strategies, and initiating remediation activities.

- Implement and oversee the qualification and validation life cycle for both software and equipment (IQ, OQ, PQ).

- Draft, review, and approve proposed changes to systems and procedures as necessary to maintain compliance and efficiency.

- Prepare, review, and approve protocols and summary reports to document validation activities effectively.

Qualifications and Requirements:

- Bachelor’s degree in a relevant technical discipline (e.g., Engineering, Life Sciences).

- Minimum of 4 years' experience as a contractor or consultant with small bio or pharma companies, focusing on Validation and Compliance activities.

- Proven expertise in managing Validation Master Plans and executing validation life cycle activities (IQ, OQ, PQ).

- Familiarity with GMP regulations and requirements, including 21 CFR Part 11 and relevant ICH guidelines.

- Excellent communication skills and ability to collaborate effectively with cross-functional teams.

- Proficiency in project management tools and software.

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At Conjugate Group, we are dedicated to help growing bio and pharma companies advancing there oncology research and improving patient outcomes. Join our team and contribute to our mission of making a difference in the lives of those affected by cancer. We are committed to fostering an inclusive and diverse workplace and encourage applications from all qualified individuals.