Associate Director - Customer Master Data - Product Owner - Military Veterans

Job Description

The Laboratory Operations Engineer in the Discovery, Preclinical and Translational Medicine Operations organization will be responsible for supporting process automation systems in clinical and non-clinical Regulated Bioanalytic, Vaccine Modernization laboratories. This position may provide direct support to automation maintenance, system security, data management, obsolescence initiatives and all Software Development Lifecycle and Compliance needs.

Job duties include:

• Working closely with divisional/enterprise Information teams, global infrastructure, and risk/security organizations to ensure compliant vaccine clinical programs within the Regulated Bioanalytics are supported.
• Collaborate with lab ops staff across bioanalytical labs and sites for process improvement, cross-training and cross-site support.
• Active and engaged participation in the routine operations supporting processes as well as a culture of continuous improvement at the site.
• Trouble-shooting challenging equipment/automation issues to improve performance, engage in vendor and IT support needs, respond to alarms, and implement future AI/ML capabilities as available.
• Assisting with the successful implementation of automation solutions, including both platform technologies and associated reporting needs.
• Following appropriate system validation, change control and testing documentation.
• Assisting in developing a suite of reporting, analytics and visualization solutions that support local clinical operations and administrative business processes.
• Ensuring automation systems are maintained in a validated state, as part of an active/ongoing lifecycle management program and in compliance with current GXP requirements.
• Assisting in the implementation of system change control and conducting system investigations.
• Providing support for small startup and/or existing production team to provide technical assistance in fulfilling the requirements for the team.
• Reviewing documents, preventive maintenance, and Standard Operating Procedures to ensure compliance with GXP Practice and corporate safety requirements.
• Assist in developing and supporting corrective actions for investigations related to GxP systems.
• Use technical knowledge to assure the efficient operation of a variety of automated processing and operational and informational technology systems.
• Participating in compliance audits and training programs.
• Providing client services support for business area laboratory applications.

Education:

• Bachelor's (with at least 2 years of relevant experience) or master's degree in engineering, Science, Information Technology, Robotics or related field

Required experience and skills:

• Experience supporting validation activities and all other associated Quality functions
• Demonstrated strong interpersonal skills with ability to influence and promote others through a culture of inclusion, feedback, and empowerment
• Follow Standard Operating Procedures with insight for continuous improvement
• Applies general knowledge of company business developed through education or experience
• Understands and applies regulatory/ compliance requirements relative to their role
• A problem solver/troubleshooter, skilled in Root Cause Analysis (RCA)
• Knowledge of the details of automation including wiring, electrical, device selection and integration

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Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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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:
Regular

Relocation:
No relocation

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Not Applicable

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
N/A

Job Posting End Date:
03/5/2025
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.