Chemical Process Engineer

Full Time Contract Role: Manufacturing Science & Technology Process Scientist (Technical Transfer Contractor) Location: Manati, PR Onsite Length of Contract: 1 year Position Description RCM is seeking a highly skilled, technical consultant to partner with our client's MS&T Product Scientist / Owner during high-stakes technology transfer initiatives and provide ongoing technical support to sterile commercial manufacturing operations. The successful candidate will deliver operational, technical, and scientific expertise to ensure that liquid and lyophilized parenteral manufacturing processes consistently maintain their designed and validated states. This role requires strict adherence to cGMPs, internal site procedures, and global regulatory filings. Responsibilities Technical Transfer Support: Partner with the Site Subject Matter Expert (SME) to support technical transfer projects, assisting in project plan development, team formation, and executing project charters. Process Expertise: Provide operational and scientific support for end-to-end sterile manufacturing operations, specifically focusing on liquid and lyophilized parenteral processes, formulation, and filling. Protocol Development: Design, author, and execute experimental, characterization, and validation protocols to support new product introductions and existing commercial lines. Specialized Studies: Support the planning and execution of critical process studies, including Mixing, Filling, Lyophilization, Capping, and Performance Qualifications (PQ) for Washers and Tunnels. Documentation & Data Verification: Prepare, review, and perform data verification for critical technical transfer documentation, including Validation Plans, Excipient/DP Holding Times, and Machinability studies. Cross-Functional Collaboration: Act as a core member of New Product Introduction (NPI) teams, developing and maintaining strong working relationships with division groups to ensure aligned tech transfer and productivity. Resource Integration: Assure the effective integration of plans and resources to achieve strict timelines associated with the product portfolio, validation activities, and technology transfer. Compliance & Safety: Ensure all manufacturing processes and individual operations comply with site procedures, regulatory filings, current Good Manufacturing Practices (cGMPs), and EHS regulations. Qualifications Industry Experience: Proven track record in Technical Transfers, Validation, or MS&T within a highly regulated biopharmaceutical or pharmaceutical manufacturing environment. Sterile Operations Knowledge: Deep technical knowledge of sterile commercial manufacturing operations, specifically liquid and lyophilized parenteral products. Process Verification Skills: Strong experience in executing and analyzing Mixing, Filling, Lyo, and Capping Machinability studies. Documentation Precision: Demonstrated experience drafting, reviewing, and verifying technical protocols, validation plans, and tech transfer documentation. Project Management Aptitude: Ability to manage tight timelines, track deliverables within an NPI framework, and actively participate in multi-disciplinary project meetings. Regulatory Compliance: Thorough understanding of cGMPs, FDA regulations, and global regulatory filings for sterile drug products. Communication Skills: Strong collaborative and communication skills to effectively interface with cross-functional division groups and site management. Problem-Solving: Analytical mindset capable of executing experimental characterization and troubleshooting complex process deviations. Education Minimum Requirement: Bachelor's Degree in Chemical Engineering, Mechanical Engineering, Bioengineering, Chemistry, Biology, or a closely related scientific/engineering discipline. 3+ years of experience in a pharmaceutical or biotechnology manufacturing environment. #J-18808-Ljbffr