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About the Role

Reporting to the Sr. Manager of Engineering & Facilities, this role leads a team and provides technical expertise to support company objectives in engineering design, new product introduction, technical transfer, process development, and implementation, with a primary focus on packaging equipment and automated packaging lines. Serves as the engineering point of contact for non-sterile filling and secondary packaging systems and processes. Projects may include manufacturing systems, non-sterile filling systems, packaging systems, vision systems, process piping, utility systems, facility construction and upgrades, serialization, and other packaging control systems. This position includes direct supervisory responsibilities.

Responsibilities

Guide and manage the team
Ensure the adequacy of the team's training and authorizations
Manage the team's schedule via ADP software
Carry out scheduled evaluations to assess team development and performance
Define action priorities in relation to means, resources, and deadlines
Develop the skills and autonomy of the team
Ensure budget reporting and monitoring
Ensure complete reporting to Site Management
Measure progress in achieving operating and investment budget commitments and propose refocusing actions
Engage in technical discussions with potential suppliers
Organize and write specifications based on needs and requirements
Launch calls for tenders
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 the successful commissioning of the project
Monitor the installations and commissioning of equipment
Coordinate various suppliers and vendors, ensuring compliance to 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
Serve in an expert role in writing qualification protocols, executing tests, and approving reports
Participate in operator training
Work with internal customers to define training requirements and provide technical content
Organize training in collaboration with suppliers
Study technical needs associated with new site investments
Participate in 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 the documentation of completed projects is updated
Collect technical drawings from vendors for review
Create technical drawings of the factory and update according to approved documentation practices
Familiar with Lean Methodologies, 5S/6S
Demonstrated experience identifying, designing, and implementing process, equipment, or technology changes to improve safety, quality, cost, and efficiency

Requirements

Minimum 5 years in either a manufacturing environment, or equipment and packaging technology
Experience in a regulated environment (FDA), preferred
Supervisory experience a plus
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
Proficient in P&ID reading and writing
Proficient in CAD or alternative design software
Strong project management skills, PMP preferred
Proficient knowledge of pharmaceutical cGMP or (HACCP) requirements and systems a plus
Experience with Hygienic Design / Sanitary Design preferred
Lean Six Sigma Green belt or higher preferred
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
New product introduction
Technical transfer
Process development
Packaging equipment
Automated packaging lines
Non-sterile filling systems
Secondary packaging systems
Manufacturing systems
Vision systems
Process piping
Utility systems
Facility construction and upgrades
Serialization
Packaging control systems
Budget reporting and monitoring
Supplier technical discussions
Specification writing
Call for tenders (RFP, RFS)
Project execution
Commissioning
Equipment installation
Technical troubleshooting
Problem solving
Equipment operation and validation
P&ID reading and writing
CAD or alternative design software
Project management
Pharmaceutical cGMP
HACCP
Hygienic Design / Sanitary Design
Lean Six Sigma
Lean Methodologies
5S/6S

Location

Rochester, NY

Work Type

Full-time
Onsite

Experience Level

Minimum 5 years
Supervisory experience a plus

Education Level

Bachelor’s degree in Mechanical Engineering, Electrical Engineering, or related discipline with equivalent experience
Master’s Degree considered a plus

Salary/Compensations

100,000.00 - 120,000.00 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 and 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.
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.
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!

Equal Opportunity

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.