Lead Process Engineer

Lead Process 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 280 employees.

Your role

Reporting to the Senior Manager, Engineering, Validation & Metrology,

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

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.

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.

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:
Minimum 5 years in either a manufacturing environment, or equipment and packaging technology
Experience in a regulated environment (FDA) preferred
Supervisory experience a plus
Hands on experience with small molecule solids and liquids manufacturing equipment a benefit
Experience in sterile manufacturing preferred but not required

Compensation range

100,000.00 - 115,000.00 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 compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

Learn more about us:

We are a dynamic company driven by a spirit of victory and are therefore pursuing strong growth while maintaining a close relationship with our customers and employees.

Our culture is based on 5 values: Respect, Responsibility, Trust, Courage and Innovation. We are committed to bringing these values to life with our employees by granting them a high degree of autonomy in the exercise of their profession and by encouraging their initiatives.

We are committed to providing them with working conditions and atmosphere that is conducive to their development and the expression of their potential.

We propose you to integrate a site that values the meaning of work and that entrusts our employees with a high level of responsibility.

Join us and make a difference!