Are you ready to make an impact with a globally recognized pharmaceutical leader? This company is dedicated to delivering life-changing therapies through innovation, strategic partnerships, and a relentless focus on improving patient outcomes.

They are seeking a Process Validation (APS) Consultant for an exciting initial 12-month contract in the vibrant Seaport District of Boston, MA. This role offers a highly competitive rate and the opportunity to contribute to cutting-edge manufacturing processes in a cGMP environment.

Key Responsibilities:

• Lead Aseptic Processing Simulations (APS) to ensure compliance with cGMP and regulatory standards.
• Collaborate with Quality Assurance, Manufacturing, and Engineering teams to optimize APS activities.
• Validate and support the implementation of single-use systems within manufacturing processes.
• Develop, revise, and manage critical documentation, including batch records, deviation reports, and CAPAs.
• Provide expertise in sterilization validation to ensure regulatory adherence.
• Drive project success by meeting milestones and deadlines through efficient APS execution.
• Represent APS activities during regulatory and internal audits, addressing inquiries and presenting documentation.
• Stay up-to-date on industry trends, regulatory updates, and advancements in aseptic processing technologies.

Qualifications:

• Bachelor’s degree in a scientific, engineering, or health-related field.
• 5+ years of cGMP manufacturing experience, with a focus on aseptic processing and validation.
• Deep understanding of APS execution, regulatory requirements, and industry best practices.
• Strong technical writing skills for validation and compliance documentation.
• Proven ability to address non-conformances with effective problem-solving and corrective actions.
• Excellent communication and interpersonal skills, with the ability to influence and collaborate across teams.
• Experience representing validation processes in audits or inspections is a plus.

If you’re ready to bring your expertise to a world-class pharmaceutical company, we’d love to connect. Send us your updated resume or let us know a convenient time to discuss this opportunity.

Not the right fit for you? Referrals are always appreciated—successful recommendations may qualify for our referral program.