Process Engineer

Company: PQE Group
Location: Rocky Mount
Posted on: May 14, 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, NC
Our 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