Process Engineer

Job Title: Process Engineer Location: Allentown, PA 18106 Contract Duration: 6 months+ (possible extension) Schedule: Monday–Friday, 8:00 AM–5:00 PM (Overtime before/after shift; weekend OT rare) Position Summary: The Process Engineer supports Engineering and Operations in a GMP-regulated pharmaceutical packaging environment. The role leads technology transfers, manages capital equipment projects, integrates new automation, and drives continuous improvement initiatives to enhance efficiency, throughput, and quality. This is a client-facing, fully on-site role responsible for ensuring compliance, resolving complex equipment issues, and maintaining standardized, high-performing operations. Key Responsibilities: · Lead technology transfer activities for new and existing client products, including documentation, qualification, and timeline alignment (client-facing role). · Support and execute CAPEX projects from initiation through installation, commissioning, FAT/SAT, and validation. · Develop user requirements (URS), equipment specifications, and support vendor reviews and evaluations. · Integrate new production equipment and automation to increase throughput and reduce manual processes. · Collaborate with Operations to identify and resolve workflow bottlenecks across packaging lines. · Conduct deviation investigations, CAPAs, and manage change control activities. · Author and approve technical documentation including SOPs, protocols, batch records, and validation documents. · Apply Lean, Six Sigma, and structured problem-solving methodologies to drive continuous improvement. · Ensure full compliance with GMP standards, site safety practices, and organizational values. · Perform additional engineering duties to support operational and business needs. · Nice to have: Packaging experience (vials, syringes, kitting, serialization, packaging design). · Maintain strong on-floor presence at the Allentown site ("boots on the ground"). Minimum Qualifications: · Bachelor's degree in Packaging, Electrical, Mechanical, Industrial Engineering, or related field. · 3+ years of engineering experience in a cGMP-controlled environment (pharma or food preferred). · Experience with automated packaging, labeling, assembly, or bottling equipment. · Strong technical writing ability (URS, FDS, FMEA, FAT/SAT, commissioning protocols, SOPs). · Mechanical aptitude with hands-on troubleshooting of packaging equipment. · Strong communication skills for cross-functional and client-facing interactions. · Ability to manage multiple priorities in a fast-paced environment. Preferred Qualifications: · 5–10 years of engineering experience. · Lean or Six Sigma certification.