Senior Mechanical/Electrical Engineer

Senior Mechanical/Electrical Engineer Unither Pharmaceuticals - 3.2 Rochester, NY Job Details Full-time $100,000 - $115,000 a year 1 day ago Qualifications Technical editing Mechanical drawings Bachelor's degree in engineering Blueprint creation using CAD software Commissioning phase involvement Piping diagrams drawing Full Job Description 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 320 employees.

A. 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. Serves as a subject matter expert (SME) with regards to filling and packaging systems. Projects include but are not limited to: manufacturing systems, non-sterile filing systems, packaging systems, process pumps and piping, utility systems, new facility construction and upgrades, and other control systems and applications.

B.ESSENTIAL DUTIES / RESPONSIBILITIES

Engage in technical discussions with potential suppliers Organize and write specifications based on the needs and requirements (URS) 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 feasibility and line trials, qualification protocols, execution of the tests, writing and approval of any resulting reports. 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

C.REQUIRED EDUCATION

Bachelor's degree in Mechanical Engineering, Electrical Engineering, or related discipline with equivalent experience. Master's Degree considered a plus.

D.QUALIFICATIONS/EXPERIENCE

Minimum 8 years in either a manufacturing environment, or equipment and packaging technology Proficiency in CAD and P&ID diagram creation, editing and review PMP a plus Experience in a regulated environment (FDA) a plus

E.SPECIFIC SKILLS

This position requires the ability to think in high level terms to develop engineering solutions for new processes. It also requires the ability to think in specific, detailed terms when problem solving for existing processes. Strong background in technical troubleshooting, problem solving. Detailed knowledge of packaging equipment operation, vision systems, 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. Batch processing, facilities, building utilities and infrastructure knowledge and experience. Proficient knowledge of pharmaceutical cGMP requirements and systems a plus.

F.PHYSICAL REQUIREMENTS / ENVIRONMENT

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