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About the Role

Serves as a technical resource supporting company objectives with respect to engineering design, process, and implementation, with a primary focus on machinery used in the packaging production process. Projects include manufacturing systems, non-sterile filing systems, packaging systems, process pumps and piping, utility systems, new facility construction and upgrades, Serialization, and other packaging control systems and applications.

Responsibilities

Engage in technical discussions with potential suppliers.
Organize and write specifications based on needs and requirements (URS).
Launch calls for tenders (Request for Proposal, Request for Service).
Ensure the solution designed respects established specifications.
Ensure technical choices deviating from specifications are documented and validated.
Execute projects and tasks to approved completion deadlines and within budget.
Work in partnership with external companies.
Propose and apply solutions to mitigate work delays.
Proactively alert site management to potential problems.
Ensure successful commissioning of the project.
Monitor installations and commissioning of equipment.
Coordinate suppliers and vendors, ensuring compliance with health and safety instructions.
Possess adequate technical expertise for problem resolution.
Respect data in specifications.
Communicate with Production to coordinate activities with production constraints.
Assist with commissioning activities and putting equipment into production.
Carry out an assessment after each commissioning.
Write feasibility and line trials, qualification protocols, execute tests, and write/approve resulting reports.
Participate in operator training.
Work with internal customers to define training requirements and provide technical content.
Organize training in collaboration with suppliers.
Create training documents and deliver training as an equipment/process SME.
Study 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 technical, regulatory, and quality requirements.
Take into account necessary parameters (water production, energy, etc.).
Respect flows, workshop ergonomics, and safety constraints.
Ensure 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.

Requirements

Bachelor’s degree in Mechanical Engineering, Electrical Engineering, or related discipline with equivalent experience.
Master’s Degree considered a plus.
Associate’s degree with highly relevant experience will be considered.
Demonstrated ability to perform technical troubleshooting and problem solving.
Background related to cGMP manufacturing, filling or packaging systems and equipment a plus.
Detailed knowledge of equipment operation and validation requirements.
Experience with robotics and vision systems a plus.
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.
Must be able to work on a computer for extended periods of time.
Must wear safety glasses and other protective items as required.
Ability to travel for business (Domestic and International).

Skills

Engineering design
Process engineering
Machinery support
Packaging production process
Manufacturing systems
Non-sterile filing systems
Packaging systems
Process pumps and piping
Utility systems
Facility construction and upgrades
Serialization systems
Packaging control systems
Technical troubleshooting
Problem solving
cGMP manufacturing
Filling systems
Packaging systems and equipment
Equipment operation
Validation requirements
Robotics
Vision systems
Matrix organization
Cross-functional teams
Project management
Pharmaceutical cGMP requirements

Location

Rochester, NY

Work Type

Full-time

Experience Level

Mid-level

Education Level

Bachelor's degree
Master's degree
Associate's degree

Salary/Compensations

85,000.00 - 95,000.00 USD

Benefits

100% employer-paid medical premiums
401(k) contributions: 6% match plus an additional 4% company-funded contribution
HSA contributions with wellness incentives
Annual performance bonuses
Merit increase eligibility

About the Company

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.
A world leader in sterile single dose, with 10 sites on 4 continents and more than 2400 employees.
Unither Manufacturing LLC. based in Rochester (NY), specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules, and has more than 360 employees.
A dynamic company driven by a spirit of victory, pursuing strong growth while maintaining a close relationship with customers and employees.
Culture based on 5 values: Respect, Responsibility, Trust, Courage and Innovation.
Committed to providing employees with working conditions and atmosphere conducive to their development and potential.
A site that values the meaning of work and entrusts employees with a high level of responsibility.

Equal Opportunity

We are an equal opportunity employer and are committed to fostering a workplace that is inclusive, respectful, and free from unlawful discrimination.
Employment decisions are made based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, creed, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity or expression, national origin, age, disability, genetic information, veteran status, or any other status protected by applicable federal, state, or local law, in accordance with U.S. Department of Labor (DOL) and Equal Employment Opportunity Commission (EEOC) guidelines.
Unither is an Equal Opportunity Employer.
Committed to providing reasonable accommodations for qualified individuals with disabilities and to ensuring equal employment opportunity for all applicants.