Job Overview
Process Engineer 1 role is responsible for providing engineering support to API manufacturing operations, ensuring processes are executed safely, efficiently, and in compliance with cGMP requirements. The position supports process performance, technology transfers, investigations, and operational excellence initiatives to meet client and business objectives.
Responsibilities
- Composing batch production records, cleaning records, SOPs, campaign reports, supplements, and investigation/deviation reports as needed to support production operations
- Identifying and monitoring KPIs and using process data to identify and execute improvements to new and existing products to achieve improved yields, quality, or customer expectations
- Working with Process Improvement resources where applicable to drive optimization of production
- Providing targeted training and process support to production areas, including training on new processes, as well as on-site oversight of key processing steps
- Working in a team environment that includes cross-departmental participation from Facilities, Chemical Research and Development, Regulatory, Quality Control, and Analytical Research and Development
- Developing plans and process fits for production
- Developing and maintaining IQ, OQ and PQ documents and protocols
- Leading and coordinating troubleshooting efforts where appropriate, investigating process problems and deviations, and preparing appropriate reports on findings
- Participating in HAZOPs and other S&IH reviews, and providing guidance on corrective actions when needed
- Where required, providing PFDs, energy balances, material balances, environmental calculations, and other pertinent production information
- Working with appropriate departments to set up codes, label requests, and MSDS revisions
- Completing CAPAs and audit action items as assigned
Qualifications/Skills
- Ability to integrate information from diverse areas/sources and independently develop creative solutions
- Excellent verbal and written communication and interpersonal skills, problem-solving, and organizational skills
- Demonstrated ability to work in a diverse team environment
- Proficiency with Microsoft software (Word, Excel, PowerPoint)
- Exposure to broader analytical techniques (i.e., beyond USP compendial testing). Some supervisory experience
- Experience / proficiency with various information and documentation software (SAP, TrackWise, etc.)
- Leads with Integrity and Respect; Delivers Results; Demonstrates Business Acumen; Fosters Collaboration and Teamwork; Champions Change; Engages and Inspires; Coaches and Develops
Education, Experience & Licensing Requirements
- BS in Chemical Engineering, plus 1 – 3 years of experience in manufacturing environment, preferably in pharmaceutical manufacture; or equivalent education/experience
- Knowledge of and/or direct experience in a cGMP environment is preferred
- General knowledge of chemical operations equipment and manufacturing operations
- Proficient in Windows-based environment including word processing, spreadsheet, and data base programs
