Process Engineer
About The Position
As a French pharmaceutical industrial group, Unither strives to make healthcare solutions that improve and simplify patients' lives accessible to as many people as possible. As a world leader in sterile single dose, we have 10 sites on 4 continents and more than 2400 employees. Since 2013, our site Unither Manufacturing LLC. based in Rochester (NY), specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules. It has more than 360 employees. Your role Reporting to the Process Lead, this position 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.
Requirements
- Bachelor’s degree in Chemical Engineering or related discipline with equivalent experience.
- Associate’s degree with highly relevant experience will be considered.
- Minimum 3 years in either a manufacturing environment, or equipment and packaging technology
- Strong background in technical troubleshooting, problem solving.
- Detailed knowledge of equipment operation and validation requirements.
- Ability to work in a matrix organization with cross-functional teams
- Ability to specify, procure, oversee installation, and commission systems and processing equipment.
- Strong project management skills.
Nice To Haves
- Master’s Degree considered a plus.
- Experience in a regulated environment (FDA) a plus
- Hands on experience with small molecule solids and liquids manufacturing equipment a benefit
- Experience in sterile manufacturing preferred but not required
- Proficient knowledge of pharmaceutical cGMP requirements and systems a plus.
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
Benefits
- 100% employer-paid medical premiums
- 401(k) contributions: 6% match plus an additional 4% company-funded contribution
- HSA contributions with wellness incentives
- Annual performance bonuses and merit increase eligibility
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
