Merck is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as 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.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
The Sr. Manufacturing Engineer is a member of the IPT (Integrated Process Team) and provides technical support to the vaccine bulk production area. The production includes media preparation, cell culture, viral and filtration processes as well as supporting area such as sterile goods/parts supplies and media preparation. This support will focus on investigation of manufacturing deviations, process improvement and optimization. Specifically, this individual will lead the deviation investigation to determine root cause, develop corrective actions to prevent reoccurrence and assess the impact on product quality. The incumbent will also be responsible for leading process improvement projects and implementation the productivity enhancement initiatives.
Responsibilities include, but are not limited to, the following:
* Lead in the identification and implementation of process improvement projects, productivity initiatives and corrective actions while focusing on equipment uptime, minimizing cost and maintaining process consistency
* Investigate deviations (both minor and major), with responsibility to interface with Operations, GVTE (Global Vaccine Technology & Engineering), Automation, and Quality approvers.
* Author and manage the investigations to meet key timing commitments, with well-investigated and well-documented deviation reports.
* Work with the Technology, Automation, and Quality Approvers to determine the breadth and scope of the investigation to identify the appropriate root cause, implement corrective actions, complete trending analysis, and determine product disposition.
* Foster a collaborative relationship with manufacturing floor personnel focused on high quality investigations, meaningful corrective actions, and reducing the deviation generation rate. Determine appropriate corrective actions to prevent reoccurrence of the deviation. Ensure corrective actions are effective and improve right first time (RFT).
* As part of the deviation management role, present and defend investigations during regulatory inspections, as required.
* Perform a thorough review of batch records and related GMP documentation, identifying and resolving discrepancies in a timely manner, and implementing corrective actions to improve the batch record execution/review process.
* Develop training material. Working with subject matter experts (SMEs), provide/track necessary training for operator qualification as assigned.
* Work alongside operations and lean six sigma team members to develop reliable, consistent manufacturing processes that meet cGMP requirements.
* The successful candidate must have strong problem solving skills and a hands-on approach to problem solving. The successful candidate should be able to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve it at root cause.
BS/MS in engineering preferred in chemical or industrial engineering. Other fields in scientific disciplines can be considered provided the candidate has strong, relevant and hands-on work experience.
* A minimum of 5 years relevant experience
* Familiarity with cGMPs and vaccine regulatory requirements
* Experience in problem solving and troubleshooting
* Technical writing and deviation investigation experience
* Biological product manufacturing process improvement and optimization experience
* cGMP experience in a sterile, bulk or finished pharmaceutical environment.
* Experience with formal problem solving techniques, such as root cause analysis (RCA), failure mode effects analysis (FMEA), and/or Lean Six Sigma tools.
* Experience in automation and manufacturing execution system (MES), process modeling and process improvement.
* Experience in deviation management, troubleshooting and resolving manufacturing anomalies.
* A minimum three year supervisory or project management 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. Merck'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.
merck.com/careers to create a profile and your resume for requisition # MAN001260.
Merck is an equal opportunity employer, M/F/D/V - proudly embracing diversity in all of its manifestations.
Search Firm Representatives
Please Read Carefully:
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.
Primary Location: US-NC-Durham
Employee Status: Regular
Number of Openings: 1
State or Province