Process Engineer

at  UNITHER PHARMACEUTICALS

WHO WE ARE?

We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and simplify patients’ lives to as many people as possible.
With 30 years of technological expertise, we position ourselves as a world leader in sterile single dose with 10 sites on 4 continents and more than 2000 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 280 employees.
Please note - Positions available Process Engineer & Senior Process Engineer
Pay Range for these roles are $70k - $110k/year

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
REQUIRED EDUCATION: Bachelor’s degree in Chemical Engineering or related discipline with equivalent experience.
Master’s Degree considered a plus.
Associate’s degree with highly relevant experience will be considered.

QUALIFICATIONS/EXPERIENCE:

Minimum 3 years in either a manufacturing environment, or equipment and packaging technology
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 require

Please refer the Job description for details