Facilities Engineer-Senior

Facilities Engineer-Senior

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.

Reporting to the Lead Facilities Engineer,

Work 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.

Familiar with regulated environments, specifically cGMP requirements relating to facilities and utilities.

Responsibilities include working with and/or leading the team to help troubleshoot issues then identify, develop and execute projects to reduce the likelihood of recurrence within budget. Able to design concepts with the users; providing detailed design documents for some projects (e.g. P&IDs, construction drawings); equipment and instrument specification and installation; engineering calculations, developing request for proposals to bid projects; coordination with customers, contractors and consultants;

reviewing documents, preparing capital appropriation requests, creating purchase orders, reviewing and paying invoices; monitoring progress; assisting with training; executing commissioning activities; and ensuring proper project closure.

• Engineering Guidance & Advice (40%)
• 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.
• Able to 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.
• Resolves high-level technical processing issues related to equipment operation.
• Position is, at times, hands‑on requiring troubleshooting of 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.)
• Follow through on technical project responsibilities by identifying project phases and elements; assigning personnel to phases and elements; reviewing bids from contractors for technical accuracy.
• Supports new equipment start up training initiatives as required. Works closely with maintenance and production to assure appropriate resources are trained on process and control systems.

• Determines project specifications by studying product design, customer requirements and performance standards; completing technical studies; preparing cost estimates.
• Provides design documents for appropriate capital or improvement projects including P&, process piping sizing, instrumentation, flow calculations, electrical/mechanical/pneumatic drawings, etc.
• Acts as a subject matter expert for equipment operation and equipment efficiencies.
• Assists with process improvement initiatives associated with delivering efficient process systems and controls.

• EDUCATION & EXPERIENCE:
  
  MS degree in an Engineering discipline preferred with a minimum 8 years in a manufacturing environment with responsibility for facilities, utilities or HVAC systems.
  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.
  Experience in sterile manufacturing is a benefit but is not required.
• KNOWLEDGE SKILLS & ABILITIES:
  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.
  This position…