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The Process Engineer serves as a technical resource for the design, implementation, and control of chemical processes, including manufacturing and sterile filing systems. Key duties include managing projects from specification and tendering through to commissioning, validation, and operator training.
Requires a Bachelor's degree in Chemical Engineering or a related field, with at least 3 years of experience in manufacturing or packaging technology. Candidates should have a strong background in technical troubleshooting and experience in FDA-regulated environments.
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
80,000.00 - 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:
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.
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!
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.
A world-leading pharmaceutical contract development manufacturing organization (CDMO).
Unither Pharmaceuticals, with 8 manufacturing plants (France, USA, Brazil and China) 4 commercial offices and 1 R&D platform, is the worldwide leader in sterile unit-doses contract manufacturing. Unither Pharmaceuticals manufactures several product lines, using highly innovative and competitive niche technologies such as: Liquid Stick-Pack, Sterile unit-dose (Blow Fill & Seal Technology), Multidoses with and without preservative, Pharmaceuticals bottles, Suppositories and Pessaries, etc. Our products are sold in more than 100 countries for an annual turnover of 371 million euros. Our vision is to be recognized for making affordable healthcare solutions that improve and simplify patients’ lives for as many people as possible. Our mission is to deliver innovative, competitive and sustainable solutions to our customers: pharmaceutical companies. Our promise is to consider patients’ needs in order to make successful products for our pharmaceutical customers.
Offices: 3-5 rue Saint-Georges, Paris, Ile de France 75009, FR · 151 rue André Durouchez, Espace Industriel Nord, Amiens, 80084, FR · Avenue Toussaint Catros, 33185, Bordeaux, 33185, FR · 755 Jefferson Road UNITED STATES, Rochester NY, NY 14623, US · Avenida Mario de Oliveira, Barretos, São Paulo 14781-160, BR
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