Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and simplify patients' lives to as many people as possible. With 30 years of technological expertise, we position ourselves as a world leader in sterile single dose with 10 sites on 4 continents and more than 2000 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 320 employees.

JOB SUMMARY

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. Capital Improvements Meet Requirements for Intended Use (40%) 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 coordinates and ensures 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. Technical Solutions (20%) 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&ID drawings, 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 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.