Job Description

Lead the Deviation Management team to excellence, driving process improvements and ensuring compliance in bulk vaccine manufacture. With a focus on technical expertise, leadership, and collaboration, you'll oversee deviation management, CAPA implementation, and team development, while maintaining a high level of technical knowledge and compliance with cGMP regulations. As a strategic leader, you'll drive results, develop talent, and support the integrated production team to achieve business objectives."

The West Point Technical Operations organization is seeking a highly motivated individual for a Manager - Engineering position for our deviation management team. The primary responsibility of the individual will be leading the Deviation Management team in their support of run-the-business activities associated with bulk vaccine manufacture. Support will be focused on the Deviation Management process including processing of deviations, identification and implementation of CAPAs, deviation management system metrics, trending, operations support, troubleshooting, and other related duties. The Manager will have responsibility for the performance and results of the Technical Operations Deviation Management team supporting the integrated production team (IPT).

This position will require development of technical expertise in corresponding IPT operations as well as managerial experience. Limited off-shift or weekend coverage may be required based on business unit needs and specific assignments.

Additional responsibilities include:

• Builds talent by recruiting, coaching, and developing the members of the Technical Operations team to ensure appropriate breadth, depth and skill sets across the team to maintain and drive the business forward. Provides/solicits 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, and 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.

• Approval of technical documentation including investigations, protocols, and reports etc.

• Presents technical discussions to regulatory agencies during inspection.

• Applies a continuous learning mindset to maintain a high level of technical process and system knowledge, enabling success with core responsibilities.

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

• Supports safety, environmental, and compliance initiatives as required.

Minimum Education Requirement and Experience:

• Bachelor of Science (B.S.) degree in Engineering, Sciences, or related field with five (5) years' experience in GMP manufacturing and/or technical support thereof; OR

• Master of Science (M.S.) degree in Engineering, Sciences, or related field with three (3) years' experience in GMP manufacturing and/or technical support thereof

Required Experience and Skills:

• Experience in deviation management.

• Strong problem-solving skills.

• Developed communication, leadership, and teamwork skills.

• Demonstrated leadership and ability to drive results.

Preferred Experience and Skills:

• Experience in biologics, vaccine, or bulk sterile manufacturing facilities.

• Participation in regulatory inspections

• Understanding of sterile and aseptic processing

• Personnel management/leadership

Current Employees apply HERE

Current Contingent Workers apply HERE

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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

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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

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Hazardous Material(s):

Job Posting End Date:

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Requisition ID:R328084