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Unither Pharmaceuticals in Rochester, NY is seeking an Engineering Manager to oversee the engineering design and management of packaging systems. The role involves leading a team, ensuring compliance with specifications, and managing project budgets.
The ideal candidate will have at least 5 years of experience in a manufacturing environment, strong technical troubleshooting skills, and a Bachelor's degree in Mechanical or Electrical Engineering.
This position offers a competitive salary range between $100,000 and $120,000, along with comprehensive benefits including healthcare and retirement contributions.
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.
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 Sr. Manager of Engineering & Facilities,
JOB SUMMARY:
Leads the 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 fully integrated, 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.
ESSENTIAL DUTIES / RESPONSIBILITIES:
Guide and manage the team
Ensure the adequacy of the team's training / authorizations in relation to the department projects and tasks
Manage the team's schedule via ADP software
Carry out scheduled evaluations to assess the development and performance of your team
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 (project monitoring, monitoring of investment commitments, overheads) to Site Management
Measure progress in achieving operating and investment budget commitments and propose refocusing actions if necessary.
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.
Process Innovation and Continuous Improvement
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
Familiar with Lean Methodologies, 5S/6S
Demonstrated experience identifying, designing, and implementing process, equipment or technology changes to improve safety, quality, cost, and efficiency.
Your profile
REQUIRED EDUCATION:
Bachelor’s degree in Mechanical Engineering, Electrical Engineering, or related discipline with equivalent
experience.
Master’s Degree considered a plus.
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 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, 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.
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
100,000.00 - 120,000.00 USD