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Posted on : 07 May 2017
- Our company is a biopharmaceutical company focused on serving patients with severe and rare disorders through the innovation, development and commercialization of life-transforming therapeutic products.
- Our company is the global leader in complement inhibition and has developed and markets a treatment for patients with PNH and aHUS, two debilitating, ultra-rare and life-threatening disorders caused by chronic uncontrolled complement activation.
- Our company is evaluating other potential indications for its marketed drug and is developing additional highly innovative biotechnology product candidates across multiple therapeutic areas.
- The Manufacturing Engineer will be responsible for the successful execution of projects identified by the manufacturing engineering lead through the site project priority list.
- These projects will be in several categories, including the following: new process / equipment remediation, process innovation and automation, product transfers / feature enhancement, new material & equipment qualification, process optimization, continuous improvement (CAPEX & OPEX) / cost reduction in facilities and maintenance.
- The manufacturing engineer main area of responsibility will be the technical engineering ownership of all equipment through processes such as purification, clarification, chromatography and nanofiltration.
- Additionally this position execute projects from the aseptic sterile fill finish facility and will provide technical leadership on any process or equipment issues in line with business strategies and objectives. The role will require the manufacturing engineer to understand the user requirements and work closely with vendors to ensure these requirements are incorporated into the equipment and facility.
- Responsible for projects, vendor inquires and troubleshooting of process systems.
- Participate on capital project teams through all phases of projects; these phases will include conceptual design, detailed design, equipment procurement, construction, installation, start up, commissioning, validation, and qualification.
- Responsible for initiation and completion of deviations, CAPAs, and change controls for process systems including investigations relating to equipment malfunctions
- Provide support to Manufacturing and Maintenance, including on-call support, as required.
- Ensure that new process equipment is included in the plant maintenance and calibration program.
- Plan and manage day-to-day technical support work on process and associated equipment to meet manufacturing or plant shutdown schedules while maintaining a high level of GMP compliance and being cost efficient.
- Acts as an advocate for continuous improvement activities in the sterile fill finish facility using statistical techniques, lean manufacturing tools, six sigma, design experimentation for process and equipment, FMEA, to achieve targets and cost savings.
- Ensure the equipment design meets regulatory and user requirement specifications.
- Act as the client point of contact for all vendor interactions to ensure successful design, testing and equipment delivery to site.
- Track and report out on projects using standard company templates, ensuring all necessary information is available to key Stakeholders, e.g. Operations, Quality, Validation, Finance and Engineering.
- Work closely with other site functions to ensure a smooth transition between project and operational phases
- Oversees process system upgrades
- Minimum of 4-6 years of experience working in a technical engineering role in the Pharmaceutical / Biotechnology industry.
- Knowledge of and experience with GMP manufacturing systems (i.e. aseptic filling machines, ultrafiltration systems, autoclaves, filtration housings, etc.)
- Experience in troubleshooting and providing technical support for cGMP manufacturing operations and equipment in an aseptic processing environment
- Ability to read and understand sophisticated architectural, equipment and system drawings.
- Demonstrated ability to work effectively with vendors and resolve issues in a timely and structured manner.
- Well-developed analytical, numerical and computer skills and the ability to combine hands-on activities with theoretical knowledge and expertise.
- Proven ability to work well as part of a team & on own with minimum supervision
- Good technical capabilities, communication skills, teamwork abilities and initiative.
- Other duties as required.
- HETAC Level 8 qualification in pharmaceutical, chemical or mechanical engineering or related engineering field.
- Our company is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Our company developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders.
- As the global leader in complement inhibition, our company is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders.
- Our company's metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders
- In addition, our company is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas
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