Process Engineer

Company: PQE Group
Location: Rocky Mount
Posted on: June 25, 2022

Job Description:

We are a service provider company, leader in the Pharmaceutical and Medical Device sectors since 1998, with more than 1200 employees, 45+ nationalities and 28 subsidiaries all over the world (Europe, Asia and the Americas). Joining PQE means being a part of a multicultural and challenging company, with many local and international projects, and colleagues from all over the world.Due to constant growth, PQE is looking for a new Process Engineer to support the manufacturing of parenteral products. This will initially be a 6 month contract assignment that will be worked on site in Rocky Mount, NC with a possibility of extension.Responsibilities - Experience with tech transfer, product development, writing protocols, and general lab requirements. - Perform trending and monitoring of critical quality attributes/critical process parameters to maintain product quality and to control process drift. - Implement potential process improvements in conjunction with manufacturing operations. - Participate in start-up of new facility, equipment, or processes in manufacturing. - Assist in documenting changes/updates to manufacturing processes. - Work with manufacturing, engineering and validation to implement changes to site. - Provide technical/scientific support on project deliverables, e.G. technology transfers, remediation initiatives, plan reports, etc. - Utilize small-scale production processes and use scaled-down lab processes to enable process troubleshooting. - Individual responsible for executing projects/tasks assigned by manager. - Execute laboratory studies and write technical reports summarizing laboratory results to support product impact assessments required for investigations into process discrepancies or out of specification test results. - Assure professional and quality performance in all activities, meeting times, cost and cGMP requirements. - Propose process improvement opportunities or corrective actions to increase yield, maximize production capacity, reduce product costs and decrease process variability while maintaining regulatory compliance. - Be adaptive and flexible to scheduling of engineering runs.Requirements - At least 1-2 years related process engineering experience in a GMP regulated manufacturing site, with preferred experience in aseptic environments. - Bachelor's in Science (Chemical Engineering, Materials Science, Biomedical Engineering, Biomanufacturing, etc.), Technology, or related field. - Hands on experience in process and equipment validation. - Technical expertise in GMP biotech processes that include upstream & downstream manufacturing. - Ability to manage priorities, deliverables, and schedule milestones. - Requires strong interpersonal, verbal communication, and technical writing skills.Location: Rocky Point, NCOur collaborators are engaged, developed, challenged and well-rewarded for performance.We recognize the importance of leadership at all levels of our organization in order to succeed in a challenging business environment, and we are committed to providing practical processes and programs to identify, develop and inspire all our current and future leaders.

Keywords: PQE Group, Rocky Mount , Process Engineer, Engineering , Rocky Mount, North Carolina