Process Engineer II
$70,000–$96,250 year
On-siteWest Chester, Ohio, United States
Job Summary
Own the technical process for assigned IDAP equipment, defining centerlines, critical process parameters, and operating procedures to ensure capable, repeatable manufacturing. Drive continuous improvement, validation, and troubleshooting on assigned assets, including changeover reduction, yield optimization, and maintenance reliability. Authors controlled documentation such as SOPs, batch records, and protocols while managing risk assessments and supporting regulatory inspections. Collaborate with Manufacturing, Quality, and suppliers to resolve technical issues and deliver projects on time. Requires GMP experience, IDAP technology knowledge, and ability to work limited supervision. Extended hours, evenings, and weekends may be required based on operational needs.
Required Qualifications
- Prior experience or exposure in a GMP or regulated manufacturing environment
- Demonstrated ability to follow controlled procedures and quality standards
- Prior training or hands-on experience in one or more IDAP-relevant technologies, such as mechanics, hydraulics, pneumatics, vacuum systems, electronics, PLCs, HMI, computerized systems, vision systems, aseptic/controlled environments, packaging equipment, process or cleaning validation, or change control
- Baseline proficiency in at least one of the following disciplines: automation/controls, aseptic/packaging equipment, process/materials, maintenance, or validation
- Ability to work with limited supervision, exercising independent judgment on assigned processes
- Must be able to lift or carry up to 20 lbs
- Ability to hear and distinguish sounds consistent with interpersonal and group conversation
- Must be able to work extended hours, including evenings and weekends, depending on project deadlines and operational needs
- Must be able to work occasional travel
- Must be able to perform prolonged sitting with occasional standing, walking, bending, stooping, twisting, and reaching
- Must have specific visual acuity (including extended computer use, color vision, and depth perception)
- Must be able to perform infrequent work at heights up to 5 ft
- Must be able to tolerate occasional exposure to noise, chemicals, and moving machinery
- Must be able to use personal protective equipment
- Must be able to work overtime, with or without notice, based on business needs, operational requirements, or other considerations
Desired Qualifications
- Bachelor's degree in Engineering or related science
- 2+ years of experience in a GMP or regulated pharmaceutical manufacturing environment
- Experience with project management and process-improvement methodologies (Six Sigma, Lean)
- Expertise in at least one of the following disciplines: automation/controls, aseptic/packaging equipment, process/materials, maintenance, or validation
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