Process Engineer
Unither Pharmaceuticals
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- Location
- Rochester, United States
- Job type
- Full time
- Posted
- Oct 13
- 7 days ago
Career path
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About the company
Unither Pharmaceuticals
Pharmaceuticals · 1,001 to 5,000 employees
What you'll do
- Support engineering design, process implementation and controls for manufacturing systems, facilities, utilities and equipment.
- Coordinate suppliers, commissioning, qualification, training and project documentation while meeting technical, regulatory, quality, budget and deadline requirements.
Key skills
chemical processengineering designprocess controlsprocess pipingtechnical drawingscommissioningqualification protocolhealth and safetytechnical solutionsregulatory requirements
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JOB SUMMARY:
Serves as a technical resource supporting
company objectives with respect to engineering design, process, and
implementation of chemical process and controls. Projects include but are not
limited to: manufacturing systems, sterile filing systems, process piping, utility
systems, new facility construction and upgrades, and other applications.
ESSENTIAL DUTIES / RESPONSIBILITIES:
Engage in technical
discussions with potential suppliers
Organize and write specifications based on the needs and requirements
Launch calls for tenders (Request for Proposal, Request for Service)
Ensure the solution designed respects the established specifications(s)
Ensure that technical choices which may deviate from established specifications, or the implicit expectations of internal customers are documented and validated in a formal manner.
Execute Projects and
Tasks to the approved completion deadlines and within the defined budget
Work in partnership with external companies
Propose and apply solutions to mitigate and compensate for possible work delays
Proactively alert site management to potential problems
Ensure the successful commissioning of the project
Monitor the
installations and commissioning of equipment
Coordinate the various suppliers and vendors and ensure their compliance to health and safety instructions
Possess adequate technical expertise allowing problem resolution
Respect the data in the specifications
Communicate with Production to coordinate activities with respect to production constraints
Assist with commissioning activities and in putting the equipment into production
Carry out an assessment after each commissioning
Serves in an expert role in writing the qualification protocol, execution of the tests and approval of any resulting report.
Participate in
operator training (training)
Work with internal customers to define the training requirement and provide technical content
Organize training in collaboration with suppliers
Study the technical needs
associated with new site investments
Participate in different project groups
Collect and analyze needs from internal stakeholders
Define technical solutions and implementations
Respect the technical, regulatory and quality requirements issued by Management and Quality Assurance.
Take into account the necessary parameters (water production, energy, etc.)
Respect flows, workshop ergonomics and safety constraints
Ensure the
documentation of completed projects is updated
Collect technical drawings from vendors for review and ensure they reflect the realized design
Create technical drawings of the factory and update according to approved documentation practices