i-Pharm GxP | Process Validation Consultant

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.

Created: 2025-01-14