Job Description

Job Description:

We have an exciting opportunity for an Associate Specialist to join the technical operations team for our company in Durham, North Carolina. The facility features end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories.

The Associate Specialist, Technical Operations engineer is responsible for providing technical support to the Deviation Management team within Technical Operations.

Position Responsibilities:

• Authoring and Facilitating Deviation Management Investigations.

• Performs deviation investigations aimed to prevent deviation re-occurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting a product impact assessment. Where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc.

• Implementing continuous improvement projects as well as supporting equipment and investigations 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.

• Designs and conducts experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.

• Authors and updates technical and manufacturing documents necessary for engineering studies, change control.

• Supports regulatory inspection activities for the facility

• Provides on-the-floor support of operational and technical (process/equipment) issues on the shop floor.

• Completes projects to improve the performance of our processes, including investigation Corrective/Preventative Actions (CAPAs), 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.

• Supports team safety, environmental, and compliance objectives.

• Manages project and investigation timelines to ensure key compliance and customer due dates are met; escalating any potential delays and develop remediation plans when possible.

• Collaborates effectively with the area Coaches, Operators/Mechanics, support groups, Quality, and Planning.

Required Experience and Skills:

• B.S. Degree in Engineering or Sciences.

• Communication, leadershipand teamwork skills.

• Ability to manage projects/work to schedule/time management/deadlines.

Preferred Experience and Skills:

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

• Experience using Lean/Six Sigma tools.

• Root Cause Analysis/Problem Solving

• Technical Writing

VETJOBS

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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:R334152