Process Engineer

Job Title: Process Engineer
Duration: 6 months
Location: Allentown, PA 18106
Shift time: 8:00am to 5:00pm Overtime before or after normal hours. OT on weekends would be rare.

Job Description: What will you do?
The Process Engineer plays a pivotal role in supporting the Engineering and Operations teams in a GMP-regulated pharmaceutical packaging environment. Responsibilities include leading technology transfers, driving capital equipment projects, and integrating new assets and automation to optimize operational efficiency, throughput, and quality. The individual drives continuous improvement initiatives, evaluates and implements process enhancements, and assists in resolving advanced machine issues to maintain standardized and efficient operations. This is a client facing role with responsibility to lead Commercial Technology Transfer activities and must be 100% present, on-site, at the Allentown facility.
How will you get here?
Applicants should possess at least 3 years of engineering experience in a relevant cGMP-controlled environment, with a preference for the pharmaceutical or food industry. Though with 5-10 years of experience are highly desirable.
Boots on the ground at the Allentown site.
Ensure full compliance with GMP standards, site safety practices, and what we value (Integrity, Intensity, Innovation, Involvement).
Identify and drive ongoing improvement efforts aimed at cutting costs, boosting efficiency, enhancing product quality, and streamlining workflow.
Lead technology transfer activities for new and existing client products in various stages of Commercial packaging, including documentation, qualification, and alignment to project timelines. This is a client facing role.
Support capital expenditure (CAPEX) projects from initiation through equipment installation and operational integration.
Develop equipment specifications and user requirements (URS or equivalent experience), lead vendor evaluations, drive design reviews, and perform FAT/SAT, commissioning, and validation activities.
Onboard and integrate new equipment, automation platforms, and production technologies to improve throughput, reduce manual operations, and enhance control.
Collaborate with Production and Operations to identify and resolve workflow bottlenecks and performance constraints across packaging lines.
Deep Technical Writing skills required. Protocol and Batch Record authoring are critical to success.
Conduct deviation investigations, CAPAs, and change control management.
Review, develop, and approve Engineering and Validation documents, including protocols, specifications, and SOPs.
Perform additional duties as needed to meet business and operational objectives.
Nice to have (Big plus): Prior packaging experience, including labeling of vials, labeling and assembly of syringes, kitting, serialization, and overall packaging design.
Education:
A four-year, Bachelor of Science degree from an accredited college or university in Packaging, Electrical, Mechanical, or Industrial Engineering or a related field is required.
Knowledge, Skills, Abilities
Proficiency in pharmaceutical or food packaging operations is required; Experience with automated packaging, labeling, bottling, or device assembly equipment is preferred.
Strong foundation in Lean, Six Sigma, SMED, and structured problem-solving methodologies.
Mechanical proficiency with proven experience resolving issues with packaging equipment.
Proficient in authoring equipment onboarding and qualification documentation (URS, FDS, FMEAs, FAT/SAT/Commissioning protocols, SOPs, Work Instructions).
Strong written and verbal communication skills with the ability to explain technical information to non-technical collaborators, including clients.
Proficiency with MS Office, especially Excel, for data analysis and project tracking.
Capable of supporting and advancing multiple priorities and working effectively in a fast-paced, multi-functional environment.
Physical Requirements
Ability to occasionally lift up to 10 lbs. and perform activities such as bending, reaching, and standing as needed.