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