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. 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

80,000.00 - 95,000.00 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. A Smarter Total Compensation Package At Unither, your base salary is just the beginning. Our Total Rewards include: 100% employer-paid medical premiums (a $2,000–$6,000+ annual value) 401(k) contributions: 6% match plus an additional 4% company-funded contribution HSA contributions with wellness incentives Annual performance bonuses and merit increase eligibility And more—because we invest in your health, your future, and your peace of mind. It’s a package designed to reward impact—not just hours worked. More Than Just a Paycheck At Unither, we don’t just offer competitive hourly wages—we also pay 100% of your medical premiums. That means no paycheck deductions for your healthcare, which can be worth an extra $1 to $3.50 an hour in your pocket compared to jobs where you pay part of the premium. Join us and make a difference! 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. Unither is an Equal Opportunity Employer. We are committed to providing reasonable accommodations for qualified individuals with disabilities and to ensuring equal employment opportunity for all applicants. #J-18808-Ljbffr Unither Pharmaceuticals