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 GMPregulated 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 clientfacing, fully onsite role responsible for ensuring compliance, resolving complex equipment issues, and maintaining standardized, highperforming operations.
 
Key Responsibilities:

• Lead technology transfer activities for new and existing client products, including documentation, qualification, and timeline alignment (clientfacing 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 problemsolving 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 onfloor 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 cGMPcontrolled 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 handson troubleshooting of packaging equipment.
• Strong communication skills for crossfunctional and clientfacing interactions.
• Ability to manage multiple priorities in a fastpaced environment.

 
Preferred Qualifications:

• 5–10 years of engineering experience.
• Lean or Six Sigma certification.
• Experience managing or supporting ERPbased manufacturing operations (Oracle, SAP, JDE, etc.).

 
Physical Requirements:

• Ability to occasionally lift up to 10 lbs
• Ability to stand, bend, reach, and perform onfloor activities as needed.