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C
Process Engineer
Salary not disclosed
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.
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.
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