Facilities Engineer-Senior

Unifin SAS • City of Rochester, NY

1d • Onsite

About The Position

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.

Requirements

• BS degree in an Engineering discipline required with a minimum 5 years in a manufacturing environment with responsibility for facilities, utilities or HVAC systems.
• Minimum 5 years regulated industry experience, Pharma experience preferred.
• Experience with purified water systems is highly desired.
• Strong background in technical troubleshooting, problem solving.
• Detailed knowledge of equipment operation and validation requirements.
• Proficient knowledge of pharmaceutical cGMP requirements and systems.
• Ability to specify, procure, oversee installation, and commission systems and processing equipment.
• Strong project management skills.
• Knowledge of regulatory requirements for manufacturing pharmaceutical products.
• Ability to think in high level terms to develop engineering solutions for new processes.
• Ability to think in specific, detailed terms when problem solving for existing processes.

Nice To Haves

• MS degree in an Engineering discipline preferred
• Experience in sterile manufacturing is a benefit but is not required.

Responsibilities

• Serve as a key technical resource in supporting company objectives with respect to engineering design and maintenance of Purified Water, WFI, Steam and Air Handling Equipment.
• Evaluate aged systems and make cost/benefit recommendations on where to invest capital based on future growth outlook.
• Evaluate current utility support infrastructure and future need and recommend solutions to support both with labor, training and automation.
• Troubleshoot issues, identify, develop and execute projects to reduce the likelihood of recurrence within budget.
• Design concepts with users, providing detailed design documents (e.g., P&IDs, construction drawings), equipment and instrument specification and installation, engineering calculations, developing request for proposals to bid projects.
• Coordinate with customers, contractors and consultants.
• Review documents, prepare capital appropriation requests, create purchase orders, review and pay invoices.
• Monitor progress, assist with training, execute commissioning activities, and ensure proper project closure.
• Act as Subject Matter Expert on HVAC Systems, Purified Water Systems, Steam and WFI for all internal requirements as well as explanation to regulatory bodies during audits and inspections.
• Provide investigation into root cause of failures, recommend short-term and long-term fixes.
• Evaluate systems for gaps in robustness and cGMP adherence and develop and execute plans to remediate.
• Resolve high-level technical processing issues related to equipment operation.
• Troubleshoot complex automated equipment and processes.
• Support management of complex, multidisciplinary projects including project spending and project scope changes to ensure that required deliverables are realized within approved spending limits.
• Provide input to detailed project plans and timelines using project management tools such as Microsoft Project, and coordinate and ensure timelines with other departments (QA/Validation, Engineering, Operations, outside Contractors and Vendors, etc.).
• Identify project phases and elements; assign personnel to phases and elements; review bids from contractors for technical accuracy.
• Support new equipment start-up training initiatives as required.
• Work closely with maintenance and production to assure appropriate resources are trained on process and control systems.
• Determine project specifications by studying product design, customer requirements, and performance standards; completing technical studies; preparing cost estimates.
• Provide design documents for appropriate capital or improvement projects including P&ID drawings, process piping sizing, instrumentation, flow calculations, electrical/mechanical/pneumatic drawings, etc.
• Act as a subject matter expert for equipment operation and equipment efficiencies.
• Assist with process improvement initiatives associated with delivering efficient process systems and controls.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior