Requisition ID: MAN005617
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that's committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
At the Merck Manufacturing facility in Elkton, Virginia, we currently have a Manufacturing Automation Compliance Engineer position available. The successful candidate will have the opportunity to apply their enthusiasm and technical skills in a dynamic compliance environment supporting the operation of pharmaceutical product manufacturing facilities.
- Lead/Participate in automation compliance projects and collaborate with automation engineers and computer validation coordinators
- continually evaluate the site's automation compliance posture against current and emerging standards and communicate risks and opportunities to automation and site leadership
- Coordinate with above site groups on corporate automation compliance initiatives
- Assess automation compliance risks, develop compliance strategies, and resolve compliance gaps
- Develop working knowledge of Quality Management Systems
- Develop/provide engaging and interactive training on automation compliance topics and System Development Life Cycle (SDLC) to department personnel
- Identify, interpret, and implement regulatory guidelines at the procedural level for SDLC Run & Operate Phase Controls
- Assess changes for validation requirements, including, but not limited to, document changes, process/equipment changes, and system changes
- Collaborate with customers and stakeholders to generate, assess, and implement process and procedural improvements
- Develop, implement, and maintain site SDLC documentation standards
- Provide regulatory compliance input to validation strategies
- Support compliance audits
- Maintain and improve system inventory and associated data integrity attributes
- Prepare compliance reports by collecting, analyzing, and summarizing measurement data and trends
- Maintain job knowledge in alignment with current compliance engineering practices and standards; participate in continuing education opportunities and professional organizations; read professional publications; maintain personal networks
Education Minimum Requirement:
- B.S. degree in engineering, computer science, integrated technology, or science
Required Experience and Skills:
- Two years of relevant industry experience
- Working knowledge of pharmaceutical regulatory agency requirements for automation and information systems
- Experience working under cGMP
Preferred Experience and Skills:
- Experience implementing and maintaining validated hardware and software systems
- Development and delivery of training programs
- Change management
- Management of people
- Experience managing projects
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we're inventing for life.
If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to email@example.com .
Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. 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.
Visa sponsorship is not available for this position.
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Job: Manufacturing Automation
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable):
Company Trade Name: Merck
Nearest Major Market: Harrisonburg
Nearest Secondary Market: Virginia