Job Description

West Point Technical Operations is seeking highly motivated individuals to provide engineering technical support for a vaccine packaging facility. The focus of the role involves providing technical leadership to support our product's processes, regulatory inspection support, supporting process improvement projects and floor support, and providing experienced engineering support in Deviation Management. This role will also manage a small team of direct reports. In providing technical leadership, the role involves supporting team members with respect to complex investigations. Support the review/approval of product deviation investigations.

The deviation management role includes coaching other team members and investigation of complex process deviations (i.e. identifying root cause, recommending corrective/preventative actions, assessing product impact, and summarizing investigations in writing). In addition, Technical Protocol development and execution is required to assess more complex manufacturing problems. Limited additional shift or weekend coverage may be required based on specific assignments.

The individual in this position will be responsible for the following:

• Actively using and championing the use of our company's Production System (MPS) tools, both in problem solving and day-to-day operational activities.
• Leading the resolution of technical problems originating from deviation investigations in close coordination with operations and the technical operations team members for the associated filling lines.
• Initiating vendor investigations, as required, in support of resolving component related problems impacting packaging line operations.
• Performing deviation investigations aimed to prevent deviation recurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting product impact assessment. Where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc.
• As required, manage the IPT deviation management daily huddle to evaluate potential deviations, facilitate the discussions to align with technology and quality approvers / representatives on deviation classification and impact assessment.
• Providing on-the-floor support of operational and technical issues; providing immediate responses on the shop floor to deviations and potential deviations
• Collaboration across IPT functional areas to drive robust processing and continuous improvement. Continuous improvement may include proactive process improvements, investigation Corrective/Preventative Actions (CAPAs), or value capture projects that seek to improve yield, reduce cost, or lower cycle times.
• Supporting team and IPT safety, environmental, and compliance objectives.
• Managing investigation timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans when possible.
• Authoring and updating technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.
• Authoring notifications to applicable Health Authorities, in response to deviations or complaints, as required.
• Supports and/or executes continuous improvement projects that increase compliance, simplify/ standardize and/or gain efficiencies.
• Provides technical support to manufacturing for complex problems and issues including process/equipment.
• Collaborates effectively with the area Operators/Mechanics, support groups, Quality, and Planning.

Minimum Required Education and Experience:

• Bachelor's degree in chemical engineering, mechanical engineering, biological sciences, packaging science or related discipline with four (4) years' experience in pharmaceutical manufacturing, project engineering, quality operations or equivalent experience. OR
• Master's degree in chemical engineering, mechanical engineering, biological sciences, packaging science or related discipline with two (2) years' experience in pharmaceutical manufacturing, project engineering, quality operations or equivalent experience.

Required Experience and Skills:

• Minimum 1-year experience in investigating manufacturing issues through either the Deviation Management Process or Complaints Process.
• Minimum 1-year experience of direct support to manufacturing operations.
• Prior leadership experience
• Prior operations experience
• Track wise, MIDAS, SAP
• Technical writing (e.g. investigations, technical protocols/reports)
• Experience in Protocol Development
• Investigative tools (e.g. 5-whys, fishbone)
• Experience in utilizing the 8-Step Problem Solving method for manufacturing issues.
• Experience in applying our company's Production System (MPS) tools and mindset, both in problem solving and day-to-day operational activities
• Experience in the Reliance Vendor Case system.

Preferred Experience and Skills:

• Minimum 7-years' experience in pharmaceutical manufacturing, project engineering, quality operations or equivalent experience
• Minimum 2-years' experience in investigating manufacturing issues in the Deviation Management Process

Current Employees apply HERE

Current Contingent Workers apply HERE

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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:

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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:

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Job Posting End Date:

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Requisition ID:R323019