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Job Description

Job Description:

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

Job duties include:

• Collaborate with divisional/enterprise Information teams, global infrastructure, and risk/security organizations to ensure compliant laboratory support of regulated bioanalytical laboratory programs

• Support the lifecycle of GxP equipment including the acquisition, install, maintenance, and retirement phases.

• Apply deep expertise in the computer system validation process for diverse laboratory equipment such as automated liquid handlers, plate readers, and LC-MS systems.

• Maintain service schedules for instrument maintenance, ensuring timely completion of calibration and maintenance activities in accordance with departmental SOPs.

• Coordinate service activities involving various vendors, service engineers, and facilities staff, fostering strong professional relationships.

• Develop a working knowledge of laboratory equipment, like liquid handlers, plate washers/readers, and LC-MS.

• Serve as system administrator for equipment applications, including temperature monitoring systems, assisting in the management of controlled temperature units and alarm handling.

• Collaborate with lab ops staff across bioanalytical labs and sites for process improvement, cross-training and cross-site support.

• Engage in the routine operations support, promoting a culture of continuous improvement.

• Assist in the developement of reporting, analytics and visualization solutions to support local clinical operations and administrative business processes.

• Ensure systems remain in a validated state as part of an ongoing lifecycle management program, compliant with current GxP requirements.

• Coordinate scheduling with end-users for LC and mass spectrometry systems to address arising issues.

• Reviewing documents, preventive maintenance, and Standard Operating Procedures to ensure compliance with GxP Practice and corporate safety requirements.

• Enhance the existing LAMP infrastructure to track equipment preventative maintenance (PM) in PDMB Regulated BA.

• Provide compliance support activities such as entering PM and corrective maintenance services in the electronic laboratory logbook (Signals).

• Oversee outsourced pipette calibration, maintaining records in the electronic logbook. Generate and review out-of-calibration impacts reports, share it with management and take appropriate actions.

• Perform Hamilton verification after PM/CM, documenting verification in the electronic logbook.

• Utilize technical knowledge to ensure efficient operation of various automated processing and informational technology systems.

• Participate 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 a master’s degree in engineering, Science, Information Technology, or a related field.

Required experience and skills:

• Experience in a GLP or GMP laboratory, preferably in a bioanalytical setting.

• Proven experience in validation activities and associated Quality functions.

• Demonstrated strong interpersonal skills with the ability to influence others and promote a culture of inclusion, feedback, and empowerment.

• Highly organized, and multitasking capabilities to manage multiple equipment or system schedules, documents, and maintenance tasks.

• Strong verbal and written communication skills, with comfort in interacting with diverse on-site and off-site collaborators.

• 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).

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

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:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)

EEOC GINA Supplement​

Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)

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

Search Firm Representatives Please Read Carefully

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:

04/1/2025

*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.

Requisition ID: R341832