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Senior Specialist, Engineering- Deviation Management

AT Merck
Merck

Senior Specialist, Engineering- Deviation Management

Spring House, PA

Job Description

The function of this position is to provide engineering technical support to the manufacture of liquid vaccines. The role encompasses technical services support in the areas of deviation management.

Position Responsibilities:

  • Serve as Subject Matter Expert (SME) for the Deviation Management team. With in-depth expertise, support and perform deviation investigations aimed to prevent deviation re-occurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting a product impact assessment. Where applicable, complete investigational test protocols to determine root cause.
  • Provide on-the-floor support of operational and technical issues; collaborating with the shop floor to aid in troubleshooting or to provide immediate responses to deviations and potential deviations.

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  • Actively use and champion the use of problem solving tools in support of quality notification reduction.


  • Complete projects to improve the performance of our processes, including projects aimed at improving Right-First-Time performance or preventing/reducing deviations. Question current practices or conventional thinking by suggesting alternative approaches and creative solutions.


  • Taking ownership; set high standards of performance for self and others; assuming responsibility and accountability for successfully completing assignments or tasks; self-imposing standards of excellence rather than having standards imposed.

    • Manage investigation and project timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans


  • Prepare source documentation for regulatory filings, supporting and supporting requests for regulatory inspections related to process overviews, investigations, projects and validation.


  • Building partnerships; develop and leverage relationships within and across work groups to achieve results.


  • Treat new situations as opportunities for learning or growth; actively seek to identify and communicate the benefits of changes; collaborate with others to implement changes.


  • Integrate information from a variety of sources to detect trends, associations and cause-effect relationships.

Education Minimum Requirement:

  • B.S. in Mechanical or Chemical Engineering Degree or other Engineering/Science Degree

Required Experience and Skills:

  • Demonstrated excellence in current or previous educational or professional roles
  • Minimum of 5-year post-Bachelor's degree experience in support of Production, Process Engineering, Validation, Technical Services or related experience
  • Minimum of 2-years experience in Deviation Management
  • Demonstrated ability to work both independently and as a part of a team.
  • Ability to coach and develop others for success; provide feedback, instruction and development guidance to help others excel in their current or future job responsibilities; planning and supporting the development of individual Skills and abilities.

Preferred Experience and Skills:

  • Hands-on technical experience in supporting bulk vaccine processing
  • Ability to convey technical concepts accurately and clearly
  • Experience with regulatory agency interactions
  • Ability to analyze metrics to assess progress against objectives

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.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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:
No Travel Required

Flexible Work Arrangements:
Not Applicable

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
10/30/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R317450

Client-provided location(s): West Point, PA, USA
Job ID: Merck-1053990201
Employment Type: Full Time