Operations Specialist

Requisition ID: MAN004656

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 125-year legacy. 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.

Primary activities include but are not limited to the following:

• Operations Specialist supporting the start-up of Line 116
• Leads and/or works independently as a team member on process improvement projects, validation studies, equipment troubleshooting and/or qualifications.
• Has ability to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
• Monitors the health of the process through continuous monitoring, statistical analysis, annual process review or continuing validation activities. Assures consistent application of standardized work, engineering and process tools.
• Provides technical support to manufacturing shop floor for routine problems and issues.
• Conducts and may design experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.
• Authors and updates technical and manufacturing documents necessary for process design/definition, engineering studies, process demonstrations, change control and validation.
• Participates in regulatory inspection activities for the facility.

Qualifications

Education:

• Bachelor’s Degree or higher in Engineering or Science

Required:

• Minimum of 2 years’ post-Bachelor’s Degree experience in the biological/pharmaceutical/chemical manufacturing industry (can be obtained through a combination of post-graduate education and work-related experience)

Preferred:

• Experience in aseptic manufacturing, filling operations, and lyophilization operations
• Strong technical writing and communication skills

Your role at Merckis integral to helping the world meet new breakthroughs that affect generationsto come, and we’re counting on your skills and inventiveness to help makemeaningful contributions to global medical advancement. At Merck, we’reinventing for life.

 If you need anaccommodation for the application process please email us at staffingaadar@merck.com.

 Search Firm Representatives Please ReadCarefully: 

Merckis not accepting unsolicited assistance from search firms for this employmentopportunity.  Please, no phone calls oremails.  All resumes submitted by searchfirms to any employee at Merck via email, the Internet or in any form and/ormethod without a valid written search agreement in place for this position willbe deemed the sole property of Merck.  Nofee will be paid in the event the candidate is hired by Merck as a result ofthe referral or through other means.

 Visa sponsorship is not available for this position.  For more information about personal rights under Equal EmploymentOpportunity, visit:

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Job: Manuf / Operations Tech Supply
Other Locations:
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck