Process Engineer 1

Cambrex•High Point, NC

12d•Onsite

About The Position

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.

Requirements

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)
BS in Chemical Engineering, plus 1 – 3 years of experience in manufacturing environment, preferably in pharmaceutical manufacture; or equivalent education/experience
General knowledge of chemical operations equipment and manufacturing operations
Proficient in Windows-based environment including word processing, spreadsheet, and data base programs

Nice To Haves

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.)
Knowledge of and/or direct experience in a cGMP environment is preferred

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