Mechanical​/Electrical Engineer

Mechanical / Electrical Engineer

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 300 employees.

Your role

Reporting to theLead Mechanical / Electrical Engineer,

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. 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.

B.ESSENTIAL DUTIES / 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

• 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

Your profile

REQUIRED EDUCATION:

Bachelor’s degree in Mechanical Engineering, Electrical Engineering, or related discipline with equivalent experience.
Master’s Degree considered a plus.
Associate’s degree with highly relevant experience will be considered.

QUALIFICATIONS/EXPERIENCE:
Minimum 3 years in either a manufacturing environment, or equipment and packaging technology
Experience in a regulated environment (FDA) a plus

SPECIFIC SKILLS:
This position requires the ability to think in high level terms to develop engineeringsolutions for new processes. It also requires the ability to think in specific, detailed terms when problem solvingfor existing processes.

Strong background in technical troubleshooting,…