Senior Project Engineer

Job Title: Senior Project Engineer – Pharmaceutical Manufacturing Experience: 10+ Years Industry: Pharmaceutical / Biotechnology Work Arrangement: Onsite Location: Ohio Position Summary :- We are seeking an experienced Senior Project Engineer with 10+ years of experience in pharmaceutical manufacturing, GMP-regulated environments, and aseptic fill-finish operations. The ideal candidate will have strong expertise in managing engineering projects related to pharmaceutical filling lines, equipment installation, upgrades, commissioning, qualification, and validation. The selected candidate will lead engineering activities for fill-line projects, ensuring compliance with FDA regulations, cGMP requirements, and industry standards while delivering projects within established timelines, budgets, and quality expectations. Key Responsibilities :- Lead and manage engineering projects involving pharmaceutical manufacturing equipment, particularly aseptic filling and fill-finish production lines. Oversee the installation, modification, upgrade, and commissioning of pharmaceutical filling line equipment. Ensure all engineering activities comply with cGMP, FDA 21 CFR Part 210/211, and applicable regulatory requirements. Manage project scope, schedules, budgets, resources, risk assessments, and project deliverables. Coordinate with cross-functional teams, including Manufacturing, Quality Assurance, Validation, Automation, Maintenance, and EHS. Support the design, engineering, and implementation of new filling lines and manufacturing equipment. Oversee equipment FAT, SAT, commissioning, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Review and approve engineering documentation, including URS, Functional Specifications, design documents, P&IDs, equipment specifications, and validation protocols. Identify and resolve technical issues related to filling equipment, production processes, and manufacturing systems. Ensure equipment and process changes are managed through appropriate Change Control procedures. Work closely with vendors, contractors, and equipment suppliers to ensure successful project execution. Support facility modifications, cleanroom upgrades, utilities integration, and manufacturing infrastructure improvements. Ensure projects meet safety, quality, operational readiness, and regulatory compliance requirements. Provide technical leadership and project updates to stakeholders and senior management. Required Technical Skills :- 10+ years of experience in pharmaceutical or biotechnology manufacturing engineering. Strong hands-on experience with GMP-regulated pharmaceutical fill-finish operations. Extensive experience with aseptic filling lines, sterile manufacturing, and pharmaceutical packaging equipment. Knowledge of vial filling, syringe filling, cartridge filling, and ampoule filling systems. Experience with filling line equipment installation, commissioning, qualification, and validation. Strong understanding of cGMP, FDA regulations, and pharmaceutical quality systems. Experience with FAT, SAT, IQ, OQ, PQ, and equipment validation. Knowledge of cleanroom environments, aseptic processing, and contamination control. Experience managing engineering projects from design through execution and handover. Ability to review engineering drawings, equipment specifications, P&IDs, and technical documentation. Strong vendor management, stakeholder coordination, and project leadership skills. Preferred Experience :- Experience working on pharmaceutical facility expansion or manufacturing modernization projects. Exposure to automated filling lines, isolator technology, RABS, and barrier systems. Experience with CIP/SIP systems, clean utilities, HVAC, WFI, and clean steam. Familiarity with PLC/SCADA-controlled pharmaceutical manufacturing equipment. Experience with equipment such as Bausch + Ströbel, Syntegon, IMA, or similar filling line technologies. Knowledge of FDA, EU GMP Annex 1, and sterile manufacturing requirements. NOTE:-professional references Mandatory: Candidates must provide 2 professional Manager-level references along with their resume for consideration. #J-18808-Ljbffr Virtue America