Review and assess Empower configurations to ensure they are aligned with approved requirements, established design principles, and global data standards.
Support the development and maintenance of standardized Empower configurations and drive master data standardization and process harmonization across sites.
Perform second-person reviews of Empower configurations, change control documentation, requirements, and supporting source documentation to ensure accuracy, completeness, data integrity, and compliance.
Provide technical support and guidance for LIMS Empower interfaces and Digital Method builds, including troubleshooting and assessment of configuration or integration-related issues.
Develop and execute test scripts and validation protocols supporting Empower configuration and system changes.
Collaborate with site and global teams to confirm requirements, technical design, configuration, testing, and implementation readiness.
Partner with site Empower analysts, Global Empower teams, laboratory users, validation teams, and other technical support functions, including LIMS and laboratory instrumentation teams, to deliver solutions in a timely and compliant manner.
Investigate and support resolution of Empower-related technical issues, configuration discrepancies, and master data challenges.
Effectively manage multiple assignments and priorities to meet committed implementation dates.
Build strong relationships with customers and stakeholders through responsive communication, technical expertise, and consistent delivery.
Work independently within defined objectives while proactively identifying and resolving technical or delivery challenges.
Education and Qualifications
Bachelor’s degree or higher in Computer Science, Biology, Microbiology, Pharmacy, Chemistry, Engineering, or a related scientific or technical field; or equivalent relevant experience.
Required Experience and Skills
Minimum of 4 years of hands-on Empower experience, preferably Empower 3 FR5 or higher, within a pharmaceutical or similarly regulated environment.
Experience developing Empower Custom Fields and Reporting Method to support laboratory testing like Assay, Dissolution, and Content Uniformity.
Demonstrated hands-on experience configuring and maintaining of Empower configuration, including Instrument Methods, Processing Methods, Sample Set Methods, View Filters, Custom Fields, and Report Methods.
Experience supporting integration between Empower and external laboratory systems such as LabWare LIMS.
Understanding of regulatory and data integrity expectations applicable to computerized laboratory systems used in the manufacture and testing of pharmaceutical, vaccine, biological, or sterile products.
Experience working within System Development Life Cycle (SDLC) and computerized system validation processes.
Ability to develop and execute test scripts and validation protocols and document results in accordance with established procedures.
Strong technical aptitude for computerized laboratory systems, data analysis, troubleshooting, and method/configuration evaluation.
Strong analytical and problem-solving skills with a high level of attention to detail.
Demonstrated ability to work effectively across geographically distributed teams and multiple stakeholder groups.
Flexibility to adjust working hours, up to approximately 25% of the work week when required, to support collaboration with U.S. East Coast project teams, particularly during onboarding, training, and critical implementation activities.
Preferred Experience and Skills
Experience with LabWare LIMS, including laboratory master data management and integration with Empower.
Experience supporting Empower in a multi-site or global pharmaceutical environment.
Familiarity with electronic document management, electronic change control, and other GxP-compliant platforms.
Experience with databases and data analysis technologies, particularly Oracle and SQL.
Additional location(s) Compensation Information
Required Skills
Adaptability, cGMP Regulations, Change Management, Deviation Management, Good Automated Manufacturing Practice (GAMP), Manufacturing Quality Control, Pharmaceutical Quality Assurance, Product Disposition, Quality Auditing, Quality Management Standards, Quality Standards, Regulatory Compliance, Risk Management, Self Motivation, Strategic Planning
Preferred Skills
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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
VISA Sponsorship
Travel Requirements
Flexible Work Arrangements
Hybrid
Shift
Valid Driving License
Hazardous Material(s)
Job Posting End Date
- 11/30/2026
- 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.
