Lead Mechanical Electrical Engineer

Unither • Rochester, NY

4h • Hybrid

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. This role, reporting to the Sr. Manager of Engineering & Facilities, is responsible for leading a team and providing technical expertise to support company objectives in engineering design, new product introduction, technical transfer, process development, and implementation, with a primary focus on packaging equipment and fully integrated, automated packaging lines. The Lead Mechanical Electrical Engineer serves as the engineering point of contact for non-sterile filling and secondary packaging systems and processes. Projects may include manufacturing systems, non-sterile filling systems, packaging systems, vision systems, process piping, utility systems, facility construction and upgrades, serialization, and other packaging control systems. This position includes direct supervisory responsibilities.

Requirements

• Bachelor’s degree in Mechanical Engineering, Electrical Engineering, or related discipline with equivalent experience.
• Minimum 5 years in either a manufacturing environment, or equipment and packaging technology
• Experience in a regulated environment (FDA), preferred
• 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.
• Proficient in P&ID reading and writing
• Proficient in CAD or alternative design software
• Strong project management skills, PMP preferred.
• Proficient knowledge of pharmaceutical cGMP or (HACCP) requirements and systems a plus.
• Experience with Hygienic Design / Sanitary Design preferred.
• Lean Six Sigma Green belt or higher preferred.

Nice To Haves

• Master’s Degree considered a plus.
• Supervisory experience a plus
• PMP preferred.
• Proficient knowledge of pharmaceutical cGMP or (HACCP) requirements and systems a plus.
• Experience with Hygienic Design / Sanitary Design preferred.
• Lean Six Sigma Green belt or higher preferred.

Responsibilities

• Guide and manage the team
• Ensure the adequacy of the team's training / authorizations in relation to the department projects and tasks
• Manage the team's schedule via ADP software
• Carry out scheduled evaluations to assess the development and performance of your team
• Define action priorities in relation to means, resources and deadlines
• Develop the skills and autonomy of the team
• Ensure budget reporting and monitoring
• Ensure complete reporting (project monitoring, monitoring of investment commitments, overheads) to Site Management
• Measure progress in achieving operating and investment budget commitments and propose refocusing actions if necessary.
• 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
• Familiar with Lean Methodologies, 5S/6S
• Demonstrated experience identifying, designing, and implementing process, equipment or technology changes to improve safety, quality, cost, and efficiency.

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: Manager