Specialist, Engineering

Tasks Participate in or manage Quality Notification investigations and change management activities. Order process consumables used in GMP manufacturing activities. Submit supply chain requests to Third Party Quality Management. Research and manage supplier notifications at direction of supplier notification lead. Prepare, review, and update GMP documentation (SOPs, Bills of Materials, Batch Records). Serve as content expert and trainer for select procedures. Perform data entry and electronic log creation/management. Support PAS‑X administrative work (PVL updates, Change Controls, Manufacturing Order creation, coordinating QA approval). Assist with warehouse coordination (scheduling sampling, risk release management, deliveries, SAP management). Assist with equipment troubleshooting and calibration coordination. Support continuous improvement initiatives. Support safety, compliance, and GMP initiatives (area walkthroughs; managing/closing observations). Developmental role with opportunity to build toward a front‑line manager position; some overtime/weekends/occasional second shift and on‑call phone required. Experience / Skills Comprehension of GMP regulatory guidelines; work collaboratively with raw material release, facility operations, equipment engineering, process operations, safety, manufacturing, and quality teams. Education BS/BA in Biological Sciences, Chemistry, Engineering, or equivalent combination of education and experience. Qualifications Knowledge of current GMP regulations; independent and team work. Ability to manage multiple priorities; problem‑solving and technical communication skills. Proficiency with Microsoft Office (including SharePoint and Power Platform). Preferred PAS‑X, SAP/Ariba, Electronic Supplier Transparency Request, ETQ Reliance. Union environment experience; relevant manufacturing/processing (aseptic/sterile, bulk, solid oral dosage, packaging). Required Skills (keywords) Biological Sciences cGMP Guidelines GMP Compliance Personal Initiative Pilot Plant Operations Process Engineering/Operations/Optimization Product Formulation Regulatory Compliance SOP Writing Sterile Manufacturing Therapeutic Proteins #J-18808-Ljbffr