Mechanical​/Electrical Engineer

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We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and simplify patients’ lives for 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 300 employees.

Reporting to the Lead Mechanical / Electrical Engineer.

• JOB SUMMARY:
  
  Serves as a technical resource supporting company objectives with respect to engineering design, process, and implementation with primary focus on machinery used in the packaging production process. Projects include but are not limited to: manufacturing systems, non-sterile filing systems, packaging systems, process piping, utility systems, new facility construction and upgrades, Serialization and other packaging control systems and applications.
• Engage in technical discussions with potential suppliers and organize and write specifications based on needs and requirements.
• Launch calls for tenders (Request for Proposal, Request for Service) and ensure the solution respects established specifications.
• Document and validate any deviations from established specifications in a formal manner.
• Execute projects and tasks to approved deadlines and within defined budgets.
• Work in partnership with external companies; propose and apply solutions to mitigate delays; proactively alert site management to potential problems.
• Ensure successful commissioning of projects and monitor installations and commissioning of equipment.
• Coordinate suppliers and vendors and ensure compliance with health and safety instructions.
• Apply technical expertise to resolve problems and respect data in specifications; communicate with Production to coordinate activities with respect to production constraints.
• Assist with commissioning activities and putting equipment into production; carry out assessments after commissioning.
• Provide expert support in writing qualification protocols, executing tests, and approving resulting reports.
• Participate in operator training, define training requirements with internal customers, and organize training with suppliers.
• Study technical needs for new site investments and participate in project groups to define technical solutions and implementations; ensure compliance with technical, regulatory, and quality requirements.
• Respect parameters such as water production, energy, flows, ergonomics and safety constraints; ensure documentation of completed projects is updated.

Bachelor’s degree in Mechanical Engineering, Electrical Engineering, or related discipline with equivalent experience. Master’s Degree considered a plus. Associate’s degree with highly relevant experience will be considered.

• Minimum 3 years in either a manufacturing environment, or equipment and packaging technology.
• Experience in a regulated environment (FDA) a plus.

• Ability to think in high level terms to develop engineering solutions for new processes, and in specific, detailed terms for existing processes.
• Strong background in technical troubleshooting and problem solving.
• Detailed knowledge of equipment operation and validation requirements.
• Ability to work in a matrix organization with cross-functional teams and to specify, procure, oversee installation, and commission systems and processing equipment.
• Strong project management skills and knowledge of pharmaceutical cGMP requirements (a plus).

Traditional office environment with frequent visits to production areas, loading docks, and laboratories. Must be able to work on a computer for extended periods. Safety glasses and other protective items as required. Sitting 75% of the day; standing or walking 25%. Ability to travel for business (domestic and…