Process Engineer

Process Engineer

Who we are?

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.

Your role

Reporting to the Process Lead,

JOB SUMMARY:

Serves as a technical resource supporting company objectives with respect to engineering design, process, and implementation of chemical process and controls. Projects include but are not limited to: manufacturing systems, sterile filing systems, process piping, utility systems, new facility construction and upgrades, and other applications.

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 Chemical 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:

SPECIFIC

SKILLS:

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.

Minimum 3 years in either a manufacturing environment, or equipment and packaging technology

Experience in a regulated environment (FDA) a plus

Hands on experience with small molecule solids and liquids manufacturing equipment a benefit

Experience in sterile manufacturing preferred but not required

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.

PHYSICAL REQUIREMENTS / ENVIRONMENT:

Traditional office environment, with frequent visits to other areas of the facility, including production areas, loading docks, and laboratories.

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)

Compensation range

80,000. USD

* The referenced compensation range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's…