Description
Staff Engineer br/ br/ Merck and Co. Inc., established in 1891, is a global research-driven pharmaceutical company dedicated to putting patients first. BR br/ br/ Join us and experience our culture first-hand - one of strong ethics and integrity, diversified experiences and a resounding passion for improving human health. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. BR br/ br/ Merck's Biological Sterile Validation Responsible (BSV) department, located in West Point, PA, is currently seeking a Staff Engineer/Staff Scientist. BSV's responsibilities include providing documented evidence that filters, containers and closures are integral through challenges against pre-established criteria for all vaccines (worldwide) and sterile pharmaceuticals (West Point). The Filter Validation, Container Closure Integrity, and Bio/Sterile Validation Laboratory team (FV/CCI/BSV Lab) supports filter and container closure validation activities end to end in West Point, Elkton, Durham, Mirabel, Boulder, and Carlow from incoming components to fill/finish. br/ br/ Incumbent will support validation activities associated with the development and support of new and existing products, processes, systems, and facilities. Position involves validation activities associated with the manufacture of multiple bulk vaccine products. Provides technical support to help develop and execute project plans. Obtains and analyzes relevant data and prepares appropriate reports for regulatory commitments and validation improvement initiatives. May be responsible for leading teams to efficiently accomplish project goals. Acts as a contributor on Merck Lean Six Sigma teams. br/ br/ Responsibilities include, but are not limited to: br/ br/ As directed, maintains a resident liaison function with Operations, Quality, and Merck Research Laboratories (MRL). Maintains alignment with internal technical personnel regarding products, equipment, and processing techniques. br/ br/ Leads execution of validation activities for both new and inline products. br/ br/ Assist in segments of technology transfer for new products or unit operations from MRL including filter and container/closure selection and verification in support of validation activities. br/ br/ Implements technology-driven productivity improvements. Designs experimental or investigational studies to improve equipment and processes in a lean service environment. br/ br/ Troubleshoots and effectively resolves manufacturing problems. Develops and implements corrective actions during deviation investigations to ensure a consistent and reliable supply of vaccines and sterile products. br/ br/ Provides contributions to the planning, design, and implementation of segments of new or upgraded process facilities and equipment in a cost effective and timely manner. br/ br/ Prepares and/or provides review and guidance for regulatory filings, process B Description /b s, deviation reports, and change requests. br/ br/ Supports all quality and safety initiatives. br/ br/ Education: br/ br/ B.S in Engineering, Biological Sciences, Chemistry or Physics. M.S. in Engineering, Biological Sciences, Chemistry or Physics preferred. br/ br/ B Required: /b br/ br/ Minimum of 4 years work experience required; with 2 years of work experience specifically in the field of validation. br/ br/ Specific experience in at least one of the following areas is required: br/ br/ Filter performance qualification using Filter Integrity testers, bubble point, and diffusive flow testing. Experience in validation desired; alternatively, experience in engineering or operations is acceptable with use of sterilizing filters, tangential flow filtration, ultra filtration, and vent filters. br/ br/ Container/ Closure Integrity testing using microbial ingress and helium leak testing. Experience in validation desired; alternatively, experience in engineering or operations using welders, sealers, and aseptic fluid transfers using sterile bags and manifolds is acceptable. br/ br/ Experience in a GMP or ISO13485 laboratory performing microbiology, environmental monitoring or engineering development work. Support the GVTE / BSV Lab Coordinator, with performing instrument qualification, metrology, SOP development , creating training material, lab notebook review, performance of internal audits (chemical hygiene, safety, 5S, GMP), and carrying out improvements activities and corrective actions in response to audits. br/ br/ BR Consistently cited as a great place to work, we discover, develop, manufacture and market a wide range of vaccines and medicines to address unmet medical needs. Each of our employees is joined by an extraordinary sense of purpose - bringing Merck's finest achievements to people around the world . br/ br/ BR We offer an excellent salary and an industry-ranked benefits program, including tuition reimbursement, work-life balance initiatives and developmental programs at all levels. Merck's retirement package includes a pension plan and one of the best 401(k) plans in the nation. br/ br/ merck.com/careers to create a profile and your resume for requisition #ENG002123. BR BR Merck is an equal opportunity employer, M/F/D/V - proudly embracing diversity in all of its manifestations. BR br/ br/ Our work is someone's hope. Join us. BR br/ br/ Where patients come first - Merck br/ br/ Search Firm Representatives br/ br/ Please Read Carefully: br/ br/ Merck is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means. br/ br/ Primary Location: US-PA-West Point
Details:
Job Id:
655659A0
Annual Salary:
Position Type:
Education Level:
No Selection
Experience Level:
No selection
Posted:
10/24/2009 2:31:44 AM
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