Laboratory Operations Engineer, Specialist

Job title: Laboratory Operations Engineer, Specialist in Lower Gwynedd, PA - Spring House, PA at MSD Company: MSD Job description: Job DescriptionJob 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 automation 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, installation, 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 PCR 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 PCR.
• 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 supports 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.
• 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.
• 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.
• 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 in engineering, Science, Information Technology, or a related field 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 into 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).

#eligibleforerpCurrent Employees applyCurrent Contingent Workers applyUS 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 if you need an accommodation during the application or hiring process.As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.U.S. Hybrid Work ModelEffective 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 OrdinanceLos 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 OrdinanceSearch 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: RegularRelocation: No relocationVISA Sponsorship: NoTravel Requirements: 10%Flexible Work Arrangements: Not ApplicableShift: 1st - DayValid Driving License: NoHazardous Material(s): N/ARequired Skills: Adaptability, Adaptability, Business Processes, Calibration Management Software, Clinical Process, Clinical Workflows, Compliance Support, Computer Technology, Detail-Oriented, Electronic Common Technical Document (eCTD), Employee Training Programs, Good Laboratory Practices (GLPs), Information Communication Technology (ICT), Maintenance Management, Management Process, Mentorship, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Experience, Regulatory Reporting, Regulatory Strategy Development {+ 4 more}Preferred Skills:Job Posting End Date: 06/5/2025*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. Expected salary: Location: Lower Gwynedd, PA - Spring House, PA Apply for the job now! Apply for this job