Job Description

The Associate Director in Digital Manufacturing Operations at West Point, PA is a lead for the manufacturing automation team supporting manufacturing of our vaccine products. This position will direct and prioritize workload activities of a professional staff of 5-10 engineers to provide process automation support to enable a reliable and compliant supply of vaccines. The responsibilities include the resolution of automation problems, implementation of process control, data collection and analysis, and troubleshooting in compliance with System Development Life Cycle (SDLC), GMP, safety, and environmental regulations.

The successful candidate will have the opportunity to apply their passion, technical skills, and leadership skills as a member of a multidisciplinary team supporting vaccine manufacturing.

Compliance

• Accountable for maintaining compliance of computerized systems in manufacturing areas through periodic review, deviation management, change control and validation.

• Ensure our team and the systems are compliant to cGMP, System Development Lifecycle and the inspection-ready state.

Supply

• Provide process automation (IT/OT) support to enable reliable supply of vaccine manufacturing.

• Manage priorities, deliverables and schedule aligned with the production needs and stakeholders.

• Manage work and resource load including internal, external and temporary resources.

• Communicate daily with the business, technical, and quality representatives within the area of support through the tier process.

• Provide off-site weekend/evening automation phone or on-site support on a rotational basis.

People management

• Responsible for creating and sustaining a highly engaged team.

• Provide coaching on professional development career paths for direct reports through mentoring, on-the-job training, as well as official training.

• Provide feedback and input on performance evaluations

Financial Stewardship

• Understand our impact the cost and finances of the business.

• Manage small capital project budgets

Continuous improvement

• Identify efficiency in our automation system

• Identify future upgrade/replacement options for aging systems.

• investigate automation anomalies and implement preventive actions

Position Qualifications:

Education Minimum Requirement:

• Bachelor's degree in Engineering, Science, Information Technology or other relevant discipline.

Required Experience and Skills:

• Minimum ten (10) years in pharmaceutical process automation or equivalent

• Ability to manage a team

• Experience inAutomation Platforms such as DCSs (DeltaV), PLCs (Allen Bradley, Siemens), SCADA, Data Historians (OSI PI), Batch Reporting (Informetric Info Batch)

• Demonstrated ability to communicate effectively and to build relationships with team, peers and area leads.

• Demonstrated leadership in achieving shared objectives in a matrix organization.

• Strong understanding of manufacturing principles/ processes and ability to translate. manufacturing requirements into Automation/digital solution.

• Strong understanding of aseptic and sterile operation.

• Experience in all aspects of GMP Change Control and Computer System Validation.

• Proven track record of analytical skills, problem solving and attention to detail.

Preferred Experience and Skills:

• Experience leading or managing teams.

• Networking protocols, Virtual Machines, Database management and other general Information Technology administration.

• Experience in biologics, vaccine or sterile manufacturing facilities.

Current Employees apply HERE

Current Contingent Workers apply HERE

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As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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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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Job Posting End Date:

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Requisition ID:R349475