Process Engineer

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 2,400 employees. Since 2013, our site Unither Manufacturing LLC 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.

About the role

Reporting to the Process Lead, this role serves as a technical resource supporting company objectives with respect to engineering design, process, and implementation of chemical process and controls. Projects include manufacturing systems, sterile filling systems, process piping, utility systems, new facility construction and upgrades, and other applications.

Responsibilities

• Engage in technical discussions with potential suppliers
• Organize and write specifications based on needs and requirements
• Launch calls for tenders (Request for Proposal, Request for Service)
• Ensure the solution designed respects established specifications
• Document and validate technical choices that deviate from specifications or internal customer expectations
• Execute projects and tasks to approved completion deadlines and within 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 successful commissioning of projects
• Monitor installations and commissioning of equipment
• Coordinate suppliers and vendors, ensuring compliance with health and safety instructions
• Resolve problems using technical expertise
• Communicate with Production to coordinate activities with respect to production constraints
• Assist with commissioning activities and putting equipment into production
• Conduct assessments after each commissioning
• Serve as an expert in writing qualification protocols, executing tests, and approving reports
• Participate in operator training and define training requirements with internal customers
• Organize training in collaboration with suppliers
• Study technical needs associated with new site investments
• Participate in project groups and collect/analyze needs from internal stakeholders
• Define technical solutions and implementations while respecting technical, regulatory, and quality requirements
• Consider parameters such as water production and energy, respecting flows, workshop ergonomics, and safety constraints
• Update documentation of completed projects
• Collect and review technical drawings from vendors to ensure they reflect the realized design
• Create and update technical drawings of the factory according to approved documentation practices

Requirements

• 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
• Minimum 3 years in a manufacturing environment or with 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

Skills

• Ability to think in high-level terms for developing engineering solutions and in detailed terms for problem-solving
• Strong background in technical troubleshooting and 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

Work Environment

• Traditional office environment with frequent visits to production areas, loading docks, and laboratories
• Must be able to work on a computer for extended periods
• 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)

Pay

Compensation range: $80,000.00 - $95,000.00 USD. Individual annual salaries will be set within this range, considering factors such as market data, education, experience, qualifications, expertise, and internal equity.

Benefits

• 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

At Unither, your base salary is just the beginning. Our Total Rewards include comprehensive benefits designed to invest in your health, future, and peace of mind. We also pay 100% of your medical premiums, which can add an extra $1 to $3.50 an hour in value compared to jobs where you pay part of the premium.

About Us

We are a dynamic company driven by a spirit of victory, pursuing strong growth while maintaining close relationships with our customers and employees. Our culture is based on five values: Respect, Responsibility, Trust, Courage, and Innovation. We provide working conditions and an atmosphere conducive to development and the expression of potential, entrusting employees with a high level of responsibility. Unither is an Equal Opportunity Employer committed to providing reasonable accommodations for qualified individuals with disabilities and ensuring equal employment opportunity for all applicants.