Mechanical / Electrical Engineer

Unifin SAS • Rochester, NY

123d • $89,000 - $95,000

About The Position

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 300 employees. Reporting to the Lead Mechanical / Electrical Engineer, this position 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.

Requirements

• Bachelor’s degree in Mechanical Engineering, Electrical Engineering, or related discipline with equivalent experience.
• Minimum 3 years in either a manufacturing environment, or equipment and packaging technology
• Experience in a regulated environment (FDA) a plus
• 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.
• Strong project management skills.
• Proficient knowledge of pharmaceutical cGMP requirements and systems a plus.

Nice To Haves

• Master’s Degree considered a plus.
• Associate’s degree with highly relevant experience will be considered.

Responsibilities

• 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
• Serve 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

Benefits

• 401K Plan: Unither Matches up to 6% on Employee Contributions each pay period.
• Retirement plan: Unither has a 4% Retirement Savings Plan contribution each year on prior year earnings.
• Performance bonus: Hourly employees receive this pay out Quarterly and Salaried employees receive this Annually.
• 11 Paid Holidays per year
• Health Insurance: Benefit Premiums Paid 100% by Unither for EE, Spouse or Domestic Partner, and Children.
• Dental and Vision Insurance: Offered for Employee, Spouse or Domestic Partner, and children.
• Health Savings Account (HSA): Quarterly Contributions made by Unither in addition to Employee contributions.
• Life insurance: 2X employees Annual salary paid by Unither. Supplemental Life Insurance offered for Employee, Spouse or Domestic Partner and Children.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees