Mechanical/Electrical Engineer

Unifin SAS • Rochester, NY

7d • $85,000 - $95,000 • Hybrid

About The Position

As a French pharmaceutical industrial group, we strive 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.

Requirements

• Bachelor’s degree in Mechanical Engineering, Electrical Engineering, or related discipline with equivalent experience.
• 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.
• Demonstrated ability to perform technical troubleshooting, problem solving.
• 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.
• 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)

Nice To Haves

• Master’s Degree considered a plus.
• Associate’s degree with highly relevant experience will be considered.
• Background related to cGMP manufacturing, filling or packaging systems and equipment a plus
• Detailed knowledge of equipment operation and validation requirements.
• Experience with robotics and vision systems a plus.
• 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 (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
• 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
• As an equipment/process SME, create training documents and deliver training
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level