Senior Mechanical/Electrical Engineer

Unither Pharmaceuticals•Rochester, NY
•$110,000 - $115,000

About The Position

Unither Manufacturing LLC., part of a French pharmaceutical industrial group, manufactures Blow-Fill-Seal products, Liquid Stick-Packs, pharmaceutical bottles, tablets, and capsules at its Rochester, New York site. The Senior Mechanical/Electrical Engineer serves as a technical resource for engineering design, process, and implementation, with a primary focus on machinery used in packaging production. The position is a subject matter expert in filling and packaging systems and supports projects involving manufacturing and non-sterile filling systems, packaging systems, pumps and piping, utility systems, facility construction and upgrades, and control systems and applications. Reporting to the Lead Mechanical/Electrical Engineer, the role oversees projects from requirements and technical specifications through supplier coordination, installation, commissioning, qualification, and documentation. The engineer works with internal stakeholders, Production, suppliers, and cross-functional project groups to define needs and solutions while respecting approved budgets and deadlines, production constraints, safety, regulatory, and quality requirements. The role also supports equipment training, technical troubleshooting, feasibility studies, line trials, and updates to factory drawings and project documentation. The position is based in a traditional office environment with frequent visits to production areas, loading docks, and laboratories. Business travel, domestic and international, is required. The listed compensation range is $110,000–$115,000. Unither describes its total rewards package as including employer-paid medical premiums, retirement contributions, HSA contributions with wellness incentives, annual performance bonuses, and merit increase eligibility.

Requirements

  • Bachelor’s degree in Mechanical Engineering, Electrical Engineering, or a related discipline with equivalent experience.
  • 5–8 years of experience in a manufacturing environment or in equipment and packaging technology.
  • Proficiency in creating, editing, and reviewing CAD and P&ID diagrams.
  • Ability to develop engineering solutions for new processes and apply detailed thinking to troubleshoot existing processes.
  • Strong technical troubleshooting and problem-solving background.
  • 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.
  • Knowledge and experience in batch processing, facilities, building utilities, and infrastructure.
  • Must be able to work at a computer for extended periods.
  • Must wear safety glasses and other protective items as required.
  • Ability to travel for business domestically and internationally.

Nice To Haves

  • Master’s degree.
  • PMP certification.
  • Experience in an FDA-regulated environment.
  • Proficient knowledge of pharmaceutical cGMP requirements and systems.

Responsibilities

  • Engage in technical discussions with potential suppliers.
  • Organize and write user requirement specifications (URS) based on needs and requirements.
  • Launch requests for proposals and requests for services.
  • Ensure designed solutions comply with established specifications, and formally document and obtain validation for technical choices that deviate from specifications or internal customer expectations.
  • Execute projects and tasks within approved deadlines and budgets.
  • Partner with external companies and propose or apply solutions to mitigate work delays.
  • Proactively alert site management to potential problems.
  • Monitor equipment installation and commissioning, coordinate suppliers and vendors, and ensure compliance with health and safety instructions.
  • Resolve technical problems and ensure work respects specification data.
  • Coordinate activities with Production in consideration of production constraints, assist with commissioning and putting equipment into production, and assess each commissioning.
  • Write feasibility and line-trial documents and qualification protocols; execute tests and write and approve resulting reports.
  • Participate in operator training, define training requirements and provide technical content, and organize training with suppliers.
  • Study technical needs associated with site investments; participate in project groups; collect and analyze stakeholder needs; and define technical solutions and implementations.
  • Respect technical, regulatory, and quality requirements issued by Management and Quality Assurance, while accounting for utilities such as water and energy, flows, workshop ergonomics, and safety constraints.
  • Ensure completed-project documentation is updated, collect and review vendor technical drawings against the realized design, and create and update factory technical drawings according to approved documentation practices.

Benefits

  • 100% employer-paid medical premiums.
  • 401(k) contributions with a 6% match and an additional 4% company-funded contribution.
  • HSA contributions with wellness incentives.
  • Annual performance bonuses.
  • Eligibility for merit increases.
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