Process Engineer II

Rentschler Biopharma is a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals. From our headquarters in Laupheim, Germany, and our site in Milford, MA, USA, we offer end-to-end solutions, including bioprocess development and manufacturing, as well as related consulting activities such as project management and regulatory support. In Stevenage, UK, we have launched Rentschler ATMP Ltd. dedicated to cell and gene therapies.

We are a family-owned company with approximately 1.400 employees from 25 nationalities. What unites us at Rentschler Biopharma, is the passion for what we do. We empower our clients to help patients with serious or rare diseases. With our dedication and expertise, we convert medical research into outstanding biopharmaceuticals. Thus, we provide an important contribution to the global availability of essential therapies.  Going forward, we are expanding our team to ensure our long-term sustainable growth. Join us and be part of a unique journey, shaping the future of biopharmaceutical manufacturing together!  

Duties and Responsibilities 

• Participate on project teams through all phases of engineering projects related to process equipment including conceptual design, detailed design, equipment procurement, construction, installation, start up, commissioning, validation, and qualification of facilities and/or equipment
• Support the manufacturing department in capital projects, partnering with QA, and QC to assure the economical selection of equipment. This includes authoring and reviewing project documents such as URS, P&ID’s, PFD’s, heat and mass balances, etc.
• Facilitate the implementation of new equipment and processes by authoring/reviewing and coordinating SOP’s, batch records and training materials
• Provide support to validation for the commissioning and qualification of new equipment or improved processes
• Support the development and review of mass balances, PFDs and PIDs, for incoming processes and specify equipment to fulfill process operations
• Work with the supply chain to define practical inventory levels for the BOMs of specific manufacturing processes. Define alternatives for BOM components if availability is an issue
• Revise methods/recipes for automated equipment such as filtration and chromatography systems
• Lead cross functional teams through equipment specification, selection, and startup
• Integrate with Process Sciences, MSAT, Quality, Facilities and Manufacturing teams for successful integration and startup of new processes / equipment at the Milford site
• Support investigations for process deviations. Complete deviation documentation and drive the implementation of effective corrective and preventative actions through change controls that eliminate repeat deviations
• Support capital request proposals by developing a business case for new technologies to improve quality, reduce costs or time
• Act as a technical SME to support startup, validation, and turnover activities for implementation of new equipment
• Lead small to medium scale capital project initiatives including scope development, schedule management, cost management and project closure
• Support asset replacement lifecycle program by leading the implementation of process and process utility equipment to ensure robust manufacturing operations
• Report to project and program leadership on cost, timelines, and technical aspects of project 
• Support the business development team by highlighting Milford’s technical and manufacturing capabilities
• Support regulatory agencies, client, and corporate audits with technical SME knowledge of process equipment and unit operations

Qualifications 

• B.S. in Life Sciences Field (Biomedical, Chemical or Mechanical Engineering preferred)
• 5+ years direct experience in the biopharmaceutical industry
• Experience with cGMP Manufacturing and Good Engineering Practices
• Strong working knowledge of Bioprocess Equipment (Ultrafiltration, Chromatography, Single Use Mixers, Buffer Prep Vessels, Temperature Control Units, Fermenters, Reactor Vessels, etc.)
• Experience with Single Use Technology / Single Use Processing equipment. 
• Knowledge of cGMP manufacturing in the detailed operations of Upstream and Downstream mAb equipment
• Knowledge of laboratory and pharmaceutical production equipment including conventional and single-use technology, autoclaves, process tanks, bioreactors, aseptic technique, clarification filters, chromatography skids and columns, UF/DF equipment, and analytical equipment
• Must have experience in collaborating within a multi-functional environment to author technical procedures, batch records, forms, deviation documentation and change control documents
• Experienced with troubleshooting approaches (problem statement, root cause analysis, FMEA, fish-bone diagrams, “5 whys”, etc.)
• Excellent interpersonal and communication skills (verbal and written).  Expected to be able to present own work to peers and cross-functional managers and influence leadership decisions 
• Demonstrated technical writing skills
• Experience with regulatory inspections (EMEA, FDA, etc.) is preferred but not required
• Knowledge of basic chemical and biological safety procedures
• Good computer skills: Use of Microsoft software (Word, Excel, Powerpoint, and Project). Familiar with Enterprise Resource Planning (ERP) systems – SAP preferred
• Support manufacturing schedules that can include alternate shifts, weekend, and holiday work at times, as dictated by the 365-day per year production schedule
• Operational knowledge of clean utility systems including WFI Generation and Distribution, Transfer Systems, CIP Skids, cleaning cycle development

Working Conditions

• Normal office working conditions: computer, phone, files, fax, copier
• Occasional support the operation of equipment used in biomanufacturing
• Personal Protective Equipment must be worn as required
• Work in clean rooms

Physical Requirements

• PPE as required