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
Click
here to apply!
|