Senior Specialist, Engineering Technical Operations

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 Senior Specialist, Engineering Technical Operations, will be responsible for the management and oversight of the Technical Services Deviation Management Team in the Live Virus Vaccine Manufacturing End-to-End at the West Point site. The primary responsibility of the individual will be leading the Deviation Management team in their support of run-the-business activities associated with vaccine technology/production in support of bulk vaccine manufacture. Support will be focused on the Deviation Management process including operations support, equipment troubleshooting, implementation of process/ equipment actions, and other related duties. The Senior Specialist will have responsibility for the performance and results of the Technical Services Deviation Management team supporting the IPT. This position will require development of technical expertise of corresponding IPT operations and managerial experience. Limited off-shift or weekend coverage may be required based on business unit needs and specific assignments. This position includes direct management of the DM team.

Additional Responsibilities

• Builds talent by coaching and developing the members of the Technical Services team to ensure appropriate breadth, depth, and skill sets across the team to maintain and drive the business forward

• Provides and receives regular feedback from team and colleagues

• Develops technical/professional staff through coaching, assignment selection and associated training

• Manages team resources and prioritizes as aligned with business needs to include run the business support (e.g. investigations) and continuous improvement activities

• Collaborates and engages with multiple functional organizations such as Operations, Technology, Quality, Automation, Global Engineering Services, Procurement, Finance, Above Site Technology, Regulatory, among others, to develop and maintain processes that meet cGMP and business requirements

• Provides technical guidance to staff, colleagues or customers as well as anticipates and interprets the customer needs to identify solutions | Includes approval of technical documentation including investigations, protocols, and reports etc. | Presents technical discussions to regulatory agencies during inspections

Education Requirement

• Bachelor degree in Engineering or Science

Experience and Skills

Required

• Personnel Management or Deviation Management

• Minimum two years relevant work, including direct support of development or manufacturing of biologics/sterile products

• Demonstrated leadership and ability to drive results

• Strategic and effective communication, collaboration skills and ability to drive accountability

• Strong and effective problem-solving skillset

Preferred

• Vaccine manufacturing

• Participation in regulatory inspections

• Sterile processing

• Authoring investigations

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

Who we are …

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

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.

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.

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

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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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R117111