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Merck Sr Deviation Engineer in West Point, Pennsylvania

Job Description

Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities, and Validation.

The Sr. Specialist, Technical Operations Engineering position within the Shared Services E2E is responsible for providing and occasionally leading technical support to the Shared Services Incoming Materials area while actively supporting, participating in, and embracing an empowered team culture. While working primarily as an individual contributor, the individual may act as a team or project lead and lead the work of others as required. Contributes to the performance and results of a department. Provides technical guidance. Anticipates and interprets client and/or customer needs to identify and implement solutions.

  • Manage investigations from notification through closure meeting timelines to ensure key compliance and customer due dates are met; escalating any potential delays and develop remediation plans when possible.

  • Provides data analysis of investigations including incident trending reports

  • Coaches manage and develops a team of engineers through an indirect reporting relationship.

  • Leads and/or executes process improvement projects and complex investigations.

  • Examines an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.

  • Develops and assures consistent application of standardized work, engineering and process tools.

  • Provides technical support to manufacturing for complex problems and issues.

  • Designs and conducts 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.

  • Develops and assures consistent application of standardized work, engineering and process tools.

  • Leads and/or works as a team member on complete investigations, process improvement and/or projects.

  • May serve as a technical reviewer/approver for investigations, SOPs and process changes.

  • Participates in regulatory inspection activities for the facility.

Position Qualifications :

Education:

  • •B.S. Degree in Engineering or Sciences

Required Experience:

  • Five (5) years post bachelor’s degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations (or M.S. degree plus 3 years; Ph.D. degree plus 1 years).

  • Experience in biologics, vaccine or bulk sterile manufacturing facilities in a process or validation support role. Minimum 2 years experience performing Deviation Management.

  • Highly developed communication, leadership and teamwork skills.

  • Ability to manage projects to schedule and budget.

Preferred Experience:

  • Advanced degree (M.S., Ph.D.) in science or engineering.

  • Regulatory inspection presentation experience with external regulatory authority representatives.

  • Six Sigma - Black or Green Belt certification.

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.

Who we are …

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.

#LI-HW2

What we look for …

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth .

INVENT.

IMPACT.

INSPIRE.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster at https://www1.eeoc.gov/employers/upload/eeocselfprint_poster.pdf

EEOC GINA Supplement​ at https://www1.eeoc.gov/employers/upload/eeocginasupplement.pdf

OFCCP EEO Supplement at https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

OFCCP Pay Transparency Rule at https://www.dol.gov/ofccp/pdf/pay-transp%20EnglishformattedESQA508c.pdf

We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Work Week

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

None

Number of Openings:

1

Requisition ID: R38015

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