Lead Process Engineer

Unither Pharmaceuticals • Rochester, NY

62d

About The Position

Reporting to the Sr. Manager of Engineering and Facilities, JOB SUMMARY: Serves as the team lead and a technical resource supporting company objectives with respect to engineering design, process, and implementation of chemical process and controls. Serves as the engineering point of contact with regards to process systems. Projects include but are not limited to: manufacturing systems, sterile filing systems, process piping, utility systems, new facility construction and upgrades, and other applications. This position has direct supervision responsibilities.

Requirements

• Bachelor's degree in Chemical Engineering or related discipline with equivalent experience.
• Minimum 5 years in either a manufacturing environment, or equipment and packaging technology
• Experience in a regulated environment (FDA) preferred
• Supervisory experience a plus
• Hands on experience with small molecule solids and liquids manufacturing equipment a benefit
• Experience in sterile manufacturing preferred but not required
• 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.
• 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.
• Sanitary welding knowledge
• 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 requirements and systems a plus.
• 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.

Nice To Haves

• Master's Degree considered a plus.
• Associate's degree with highly relevant experience will be considered.

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
• Familiar with Lean Methodologies, 5S/6S
• Demonstrated experience identifying, designing, and implementing process changes to improve safety, quality, cost, and efficiency.
• 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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Number of Employees: 1,001-5,000 employees