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Description
Technical Support Engineer-MAN001212
Description
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 Technical Support Engineer is a member of the IPT (Integrated Process Team) and provides technical support to the vaccine formulation/filling production area. This support will focus on investigation of manufacturing deviations and review of GMP batch records. Specifically, this individual will lead the investigation of deviations to determine root cause, will develop corrective actions to prevent reoccurrence, and will assess the impact of the deviation on product quality. Routine review of batch records and associated data required for release is also a key role in this position.
Primary responsibilities include, but are not limited to the following:
* Investigation of deviations (both minor and major), with responsibility to interface with Operations, GVTE (Global Vaccine Technology & Engineering), Automation, and Quality approvers.
* Manages the investigations to meet key timing commitments, with well-investigated and well-documented deviation reports.
* Works 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.
* Fosters a collaborative relationship with manufacturing floor personnel focused on high quality investigations, meaningful corrective actions, and reducing the deviation generation rate. Determines appropriate corrective actions to prevent reoccurrence of the deviation. Ensures corrective actions are effective.
* As part of the deviation management role, presents and defends investigations during regulatory inspections, as required.
* Performs 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.
* Leads process improvement projects, productivity initiatives, change requests, implementation of corrective actions, and execution of investigational test protocols, as required.
Qualifications
Education:
B.S./M.S degree in engineering/scientific field required.
Required:
* Prior work experience in a manufacturing or process support role.
* Working knowledge of cGMPs and of regulatory requirements as they apply to the vaccine/pharmaceutical industry.
* Experience in deviation management, troubleshooting, or resolving manufacturing anomalies.
Desired:
* cGMP experience in a sterile, bulk or finished pharmaceutical environment.
* Experience with formal problem solving techniques, such as root cause analysis and/or Lean Six Sigma tools.
* Execution/review of manufacturing batch records
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 # MAN001212.
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: 2
Details:
Job Id:
34012266
Posted / Updated:
3/3/2012 3:50:17 AM
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