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Senior Specialist, Engineering

AT Merck
Merck

Senior Specialist, Engineering

Spring House, PA

Job Description

The West Point Technical Services - Measles, Mumps, Rubella (MMR) Bulk organization, is seeking a highly motivated individual for a Senior Specialist - Engineering position. The successful candidate will have the opportunity to contribute to the execution of large capital projects in the area by providing technical guidance and anticipating and interpreting customer needs to identify and implement solutions.

Responsibilities include the following:

  • Provide technical support for the execution of a large capital project for the MMR bulk manufacturing area.
  • Supports team safety, environmental, and compliance initiatives.
  • Apply technical skills to align activities with department, site and franchise objectives.
  • Lead and/or works as a team member on capital projects, continuous improvement projects, and/or validation projects.
  • Manage project timelines to ensure key compliance and customer due dates are met; escalating when necessary and developing remediation plans when possible.
  • Effectively collaborates with cross functional peers on site and above site as required.
  • Integrates initiatives into capital projects to improve the performance of our processes, including projects aimed at improving Right-First-Time performance or preventing/reducing deviations, and value capture projects that seek to improve yield/efficiency, reduce cost, or lower our processing cycle times.
  • Has ability to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve manufacturing challenges.
  • Monitor the health of the process through continuous monitoring and the annual process review or continuing validation activities.
  • Assure consistent application of standardized work, engineering and process tools.
  • Provides on-the-floor support of complex operational and technical (process/equipment) issues.
  • Author and update technical and manufacturing documents necessary for process design/definition, engineering studies, process demonstrations, change control and validation.
  • Prepare documentation to support regulatory submission and participates in regulatory inspection activities for the facility.

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Education Minimum Requirement:

  • B.S. degree in Engineering or Sciences.
  • Minimum 6 years post-bachelor's degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations (or M.S. degree plus 4 years; PhD degree plus 2 years).

Required Experience and Skills:

  • Demonstrated strategic ability to develop innovative solutions for undefined problems and business processes to meet the needs of key stakeholders and project sponsors.
  • Highly developed communication, leadership and teamwork skills.
  • Ability to manage projects to ensure timely completion of project milestones.

Preferred Experience and Skills:

  • Advanced degree (M.S., PhD) in science or engineering.
  • Expertise in Cell Culture, Virology, or Industrial Microbiology
  • Experience in biologics, vaccine or bulk sterile manufacturing facilities.
  • Good understanding of sterile and aseptic processing
  • Experience in large capital project management
  • Regulatory inspection presentation experience with external regulatory authority representatives.
  • Proficient in the following competencies: flexibility, motivation, teamwork/collaboration, problem-solving, and project management.
  • Demonstrated competency in Change Control procedures.

NOTICEFORINTERNALAPPLICANTS

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:
10%

Flexible Work Arrangements:
Hybrid

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
10/16/2024
*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:R316553

Client-provided location(s): West Point, PA, USA
Job ID: Merck-1524079980
Employment Type: Full Time