Job Description

• Work within the Laboratory Automation & IT group to transform the organization into an integrated and efficient organization that connects lab data, processes, systems, and instruments with enhanced digital capabilities and compliance.

• Participate in validation engineering projects from start-to-finish.

• Serve as a computerization validation specialist for new or upgraded laboratory instruments.

• Participate in writing system requirements.

• Configure the system software for the laboratory instruments for the specific working environment.

• Develop software testing scripts to verify requirements are met.

• Communicate with instrument end-use experts (chemist, biologist, engineer, etc.) to understand desired functionality of systems.

• Determine best process and system configuration to meet business functions.

• Ensure configuration meets company compliance requirements and specifications.

• Translate user requirements and compliance requirements into technical specifications for new or upgraded laboratory instruments.

• Develop value added system solutions.

• Develop testing steps to verify solution meets requirements.

• Write standard operating procedures for administration and/or software use of computerized systems.

• Work with groups from internal laboratories and/or work teams, other IT technical support teams, and corporate governing teams.

• Provide expert support to lab system users.

• Provide documentation/technical input during inspections and audits (Regulatory and Internal).

• Identify and leverage opportunities to continually improve the quality and effectiveness of lab systems, data management systems, processes, and standards.

• Participate in the design of the processes, and the implementation of data integrity improvements.

• Support change management for data integrity and participate in maintaining a strong data integrity culture.

Requirements:

• Master's degree or equivalent in Computer Science, Science, Engineering, Biotechnology or related discipline and 3 years of experience in the offered role or a related occupation.

• Requires 3 years of experience with all of the following: System Developmental Life Cycle (SDLC) in the pharmaceutical industry; incident management, root cause analysis and corrective action plan.

• Perform assessments of computerized/non-computerized systems with knowledge of the latest specifics of data integrity and compliance as it relates to original electronic data completeness, consistency and accuracy, as focused from global pharmaceutical regulatory agencies; BioTek Microplate reader, Agilent UV-Vis Spectrophotometer, Applied Biosystems 3500xL Genetic Analyzer, Applied biosystems Real-Time PCR System, Bio-Rad Densitometer, Wyatt DynaPro Dynamics Light Scattering System, Computer controlled Eppendorf Liquid Handling System, Computer controlled Hamilton MicroLab Liquid Handling System, Thermo Fisher Nicolet FTIR Spectrometer, Molecular Devices Microplate Reader, Rudolph Polarimeter, Sievers Total Organic Carbon (TOC) Analyzer and VERITI multi-well Thermal Cycler; system configuration, data integrity (DI) assessment, and development and implementation of technical solutions for DI gaps.

• Administration of the following: Charles River EndoSafe EndoScan-V, Image Lab, Applied Biosystems MicroSEQ ID, Applied Biosystems Data Collection software, Wyatt Dynamics, Eppendorf epBlue, Molecular Devices SoftMax Pro GxP, Molecular Devices GxP Admin, Hamilton Run Control V., Thermo Fisher OMNIC, AccuSEQ Real-Time PCR Detection, Agilent Cary UV Workstation, and Agilent Control Panel for Open Lab Software; antibiotic containment principles,

• Pharmaceutical Laboratory Business and Manufacturing Operations; McAfee Application control, SAP, and MS tools (Word, Excel, PowerPoint, OneNote, SharePoint, Teams).

• Training laboratory specialists (chemists, biologists, engineers, and related) on system operations; and Electronic Data Management Systems (EDMS) including importing/exporting documents, routing documents for review and/or approval cycle, and document rendition.

• 5% domestic & international travel required.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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, generally Tuesday, Wednesday and either Monday or 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”.

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:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

No

Job Posting End Date: 07/08/2024

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: R276352