Process Engineer
Company: PQE Group
Location: Kalamazoo
Posted on: June 23, 2022
Job Description:
PQE is a service provider company, leader in the Pharmaceutical
and Medical Device sectors since 1998. With a network of more than
900 consultants, PQE delivers the highest level of expertise to
Life Science customers worldwide and has successfully completed
12,000+ projects for 1,400+ clients. An international group, PQE
operates in over forty countries throughout Europe, Asia, and the
Americas. PQE offers worldwide coverage with offices and
representatives across Europe, North America, Asia, the Middle
East, and Latin America, in order to better serve these specific
local markets. Further information can be found at
www.pqegroup.com.
Due to constant growth, PQE is looking for a new Process Engineer.
This will initially be an 8 month contract assignment that will be
worked on site in Kalamazoo, MI with a possibility of
extension.
Responsibilities
- Provide project support in the installation, pre-commissioning
and maintenance of equipment/utilities/ancillaries, used in vaccine
formulation, fill & finish and freeze-drying processes
- Perform process engineering activities to support equipment
start-up, systems integration, process optimization, and cycle time
reductions of our vaccine formulation facilities
- Will likely be responsible for documentation development, SOP
drafting, sequence of operation optimization and documentation
- Follow standard operating procedures and standards in a highly
regulated environment
- Generate and execute protocols through GMP verification
process
- Develop new and follow existing standard operating procedures
and programming guidelines
- Contribute to design, develop, deploy and test our automated
processes, systems and equipment
- Contribute substantially to the interpretation of results and
the design of subsequent activities
- Adhere to safe work practices and develop standard operating
procedures and system support documentation
- Clearly communicate progress and issues to management and peers
and finalize report writing for test protocols
- Perform all tasks in strict compliance with operating
procedures, best practices, and regulatory requirements
- Provide feedback to leadership regarding potential issues and
concerns with documentation
- Accountable for accurately completing GMP documentation
Requirements
- At least 3 years related process engineering experience, with
preferred experience in aseptic environments including formulation,
filling, freeze drying, and/or bio-tech, with understanding of
automated process equipment, systems architecture and operations,
and related components
- One year process experience in a pharma GMP environment
strongly preferred
- Must have hands on experience with the above processes
equipment/utilities start-up (e.g. pre-commissioning),
troubleshooting, and operations experience (e.g.
preventive/corrective maintenance)
- Previous experience in equipment and process and equipment
validation is helpful, but not just focusing on this
- 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: Kalamazoo, Michigan
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, Kalamazoo , Process Engineer, Engineering , Kalamazoo, Michigan
Didn't find what you're looking for? Search again!
Loading more jobs...