Senior Specialist, Engineering Job - United States
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. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
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 Merck’s campus in Elkton, Virginia, we currently have a Senior Specialist, Engineering position available within the Technical Services – Validation team. The manufacturing facility is located in the Shenandoah Valley along the Shenandoah River and the Blue Ridge Mountains – just a short distance from the University of Virginia and James Madison University.
The successful candidate will have the opportunity to apply their enthusiasm and technical skills as a member of a multidisciplinary team supporting the operation of pharmaceutical/biopharmaceutical/vaccine product manufacturing facilities.
This role will be the Site Subject Matter Expert (SME) for Cleaning Validation; Process Validation and Continued Process Verification and report into the Elkton Validation lead.
Assignments and duties will include:
Site Cleaning SME:
◦Second person review all cleaning validation (CVAL) final reports (>131 systems).
◦Maintain site CVAL metrics (schedule adherence, RFT, CIP Robustness) for all CVAL studies executed.
◦Update CVAL due dates in site Tracker spreadsheet.
◦Provide cleaning impact assessment statements for all site change controls. (>20/mo)
◦Review and approve new/revised cleaning strategies, cleaning development, and cleaning risk assessments for all IPTs.
◦Support all internal and regulatory inspections as site SME for cleaning validation.
◦Provide consultation to TechOps/Operations when cleaning issues arise.
◦Align with the Merck network on cleaning solutions/implementation through Merck’s monthly Cleaning Validation Forum.
◦Provide Elkton feedback to the Best Practices Community for Cleaning and Changeover VTN as questions are posted.
◦Benchmark cleaning issues and cleaning validation implementation outside of Merck through the Pharmaceutical CIP Summit and Steris cleaning workshops.
◦Serve as QMS Sub-System Owner (SSO) for Chapter 13, Cleaning Validation: Complete required training, maintain site audit presentation, develop opportunities to improve the sub-system, provide annual health check summary to SLT, and close all QMS gaps.
Site Process Controls / PPQ / CPV SME:
◦Serve as QMS Sub-System Owner (SSO) for Chapter 25, Product / Process Validation: Complete required training, maintain site audit presentation, develop opportunities to improve the sub-system, provide annual health check summary to SLT, and close all QMS gaps.
◦Serve as QMS Sub-System Owner (SSO) for Chapter 23, Process Control: Complete required training, maintain site audit presentation, develop opportunities to improve the sub-system, provide annual health check summary to SLT, and close all QMS gaps.
◦Serve as site MII Administrator
◦Continued Process Verification (CPV / Stage 3) SME for the site
•achieve Safety, Quality, and Environmental compliance excellence in all assignments
•writing, reviewing, improving documentation for technical and regulatory compliance excellence
•contributing to process and equipment safety reviews
•teaching, coaching, mentoring, and learning from team members
Education Minimum Requirement:
•B.S. degree in chemical engineering, biochemical engineering, biological systems engineering, industrial engineering, mechanical engineering, biology, biochemistry, chemistry or related science or engineering discipline and a minimum of (6) six years of relevant industrial experience
Required Experience and Skills:
•GMP Manufacturing Experience
•Demonstrated project management capabilities and change control experience.
•strong problem solving skills and a hands-on approach to problem solving, with a bias toward going to see problems for oneself in the field.
•excellent technical, organizational, interpersonal, collaborative, and verbal/written communication skills are required.
•the ability to examine an issue from diverse perspectives (safety, compliance, maintenance, automation, equipment, process, and people) in order to best understand and resolve it.
•enthusiasm, confidence and initiative-taking ability needed for continuous learning and its applications.
Preferred Experience and Skills:
•Merck change control experience/expertise
•biologics or vaccine processing experience
•sterile processing experience
•CMC / regulatory submission experience
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at firstname.lastname@example.org.
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.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC GINA Supplement
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job: Chemical Engineering
Job Title:Sr. Spclst, Engineering
Primary Location: NA-US-VA-Elkton
Employee Status: Regular
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials: No
Company Trade Name:Merck
Nearest Major Market: Harrisonburg
Nearest Secondary Market: Virginia
Job Segment: Biochemistry, Pharmaceutical, Supply, Engineer, Compliance, Science, Operations, Engineering, Legal