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 supportingcompany objectives with respect to engineering design, process, andimplementation of chemical process and controls. Projects include but are notlimited to: manufacturing systems, sterile filing systems, process piping, utilitysystems, new facility construction and upgrades, and other applications.
ESSENTIAL DUTIES / RESPONSIBILITIES:

Engage in technicaldiscussions 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 andTasks 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 theinstallations 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 inoperator training (training)
Work with internal customers to define the training requirement and provide technical content
Organize training in collaboration with suppliers

Study the technical needsassociated 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 thedocumentation 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 levelterms to develop engineering solutions for new processes. It also requires the ability to think inspecific, 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 PaycheckAt 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.