POMS MES Techno-Functional SME

Capgemini; City of Albany (NY); Remoto; USD 73.000 - 174.000; Tempo pieno

Descrizione del lavoro

Capgemini Engineering in Albany, NY is seeking an experienced POMS MES Techno-Functional SME to advise on MES deployments in a GxP pharma setting. You will bridge business stakeholders, operations, quality, validation, and IT to support, configure, and implement POMS MES across sites.

The role demands deep MES expertise, regulatory awareness, and hands-on experience with CSV validation. Travel may be required as part of site implementations.

Competenze

• 8–12 years of Life Sciences or Biotech manufacturing experience.
• 5+ years supporting or implementing POMS MES solutions.
• Experience in GxP-regulated environments and CSV validation.
• Ability to translate requirements into MES designs and UAT.

Mansioni

• Collaborate with Manufacturing, Quality, Validation, and IT to gather requirements.
• Translate requirements into MES specifications, designs and implementation plans.
• Lead workshops, fit-gap analyses, design reviews and UAT.
• Configure and support MES workflows, EBRs, recipes, and MES processes.
• Review specs, assist deployments, upgrades, and release management.
• Support validation activities per FDA 21 CFR Part 11 and GAMP 5.

Conoscenze

POMS MES

GxP compliance

CSV validation

Manufacturing processes

Regulatory alignment

Troubleshooting

Stakeholder collaboration

Formazione

Bachelor's degree (Engineering/CS/IT/Life Sciences)

Strumenti

ERP systems

LIMS

SCADA

Historian

Descrizione del lavoro

# POMS MES Techno-Functional SMENew YorkApply for this job* Permanent* Experienced Professionals* Products & Systems Engineering* ID 515822-en\_USAt Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same. ## .**Location: Albany, New York OR Remote with travel on need basis****Job Description:**Capgemini is seeking an experienced **POMS MES Techno-Functional SME** with deep expertise in Manufacturing Execution Systems (MES) within a GxP-regulated pharmaceutical manufacturing environment. The ideal candidate will serve as a trusted advisor and bridge between business stakeholders, manufacturing operations, quality organizations, validation teams, and technical delivery teams to support, enhance, configure, and implement POMS MES solutions across manufacturing sites.This role requires a combination of strong functional knowledge of pharmaceutical manufacturing processes, hands-on POMS MES expertise, and familiarity with CSV validation and regulatory compliance requirements.**Your Role:****Business & Functional Responsibilities:*** Collaborate with Manufacturing, Quality, Validation, and IT stakeholders to gather, analyze, and document business requirements.* Translate business requirements into MES functional specifications, solution designs, and implementation strategies.* Lead requirements workshops, discovery sessions, fit-gap analyses, design reviews, and user acceptance testing (UAT).* Partner with manufacturing teams to optimize production workflows and leverage POMS MES capabilities to improve operational performance.* Drive alignment between MES solutions, manufacturing processes, business objectives, and regulatory requirements.* Support process harmonization initiatives across manufacturing sites.## .**MES Technical Responsibilities:*** Configure, support, and enhance POMS MES workflows, electronic batch records (EBR), recipes, and manufacturing execution processes.* Support MES module configuration, troubleshooting, and issue resolution activities.* Perform root cause analysis and corrective actions for production support issues.* Support and review MES integrations with enterprise systems such as ERP, LIMS, Historians, Automation/SCADA, and other manufacturing applications.* Review technical specifications, configuration documentation, and implementation deliverables.* Assist with system deployments, upgrades, migrations, and release management activities.* Provide expertise in electronic batch record execution, deviations management, manufacturing investigations, and exception handling.**Validation & Compliance Responsibilities:*** Support Computer System Validation (CSV) activities throughout the system lifecycle.* Author, review, and maintain validation documentation including:+ User Requirements Specifications (URS), Functional Requirements Specifications (FRS), Design Specifications (DS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)+ Validation Summary Reports (VSR)+ Ensure compliance with FDA 21 CFR Part 11, GAMP 5 Guidelines, GMP.## .**Your Skills and Experience:*** Bachelor's degree in Engineering, Computer Science, Information Technology, Life Sciences, or a related field.* 8–12 years of experience in Life Sciences, Pharmaceutical, or Biotech manufacturing environments.* 5+ years of hands-on experience supporting or implementing POMS MES solutions.* Strong understanding of MES concepts, electronic batch records (EBR), batch execution, manufacturing operations, and production workflows.* Experience working in GxP-regulated environments.* Solid understanding of pharmaceutical manufacturing processes, validation methodologies, and quality systems.* Experience supporting MES implementations, enhancements, upgrades, and production support activities.* Ability to review and interpret functional and technical documentation.* Strong troubleshooting and analytical problem-solving skills**Preferred Qualifications:*** Experience with large-scale MES implementation or site rollout programs.* Exposure to system integrations involving ERP, LIMS, Historian, SCADA, or automation platforms.* Knowledge of ISA-95 manufacturing standards and digital manufacturing architectures.* Experience supporting global manufacturing organizations.The base compensation range for this role in the posted location is $73,000 - $174,000/year.Capgemini provides compensation range information in accordance with applicable national, state, provincial, and local pay transparency laws. The base compensation range listed for this position reflects the minimum and maximum target compensation Capgemini, in good faith, believes it may pay for the role at the time of this posting. This range may be subject to change as permitted by law.The actual compensation offered to any candidate may fall outside of the posted range and will be determined based on multiple factors legally permitted in the applicable jurisdiction.These may include, but are not limited to: Geographic location, Education and qualifications, Certifications and licenses, Relevant experience and skills, Seniority and performance, Market and business consideration, Internal pay equity.It is not typical for candidates to be hired at or near the top of the posted compensation range.In addition to base salary, this role may be eligible for additional compensation such as variable incentives, bonuses, or commissions, depending on the position and applicable laws.**Capgemini offers a comprehensive, non-negotiable benefits package to all regular, full-time employees.** In the U.S. and Canada, available benefits are determined by local policy and eligibility and may include: * Paid time off based on employee grade (A-F), defined by policy: Vacation: 12-25 days, depending on grade, Company paid holidays, Personal Days, Sick Leave* Medical, dental, and vision coverage (or provincial healthcare coordination in Canada)* Retirement savings plans (e.g., 401(k) in the U.S., RRSP in Canada)* Life and disability insurance* Employee assistance programs* Other benefits as provided by local policy and eligibility**Important Notice:** Compensation (including bonuses, commissions, or other forms of incentive pay) is not considered earned, vested, or payable until it becomes due under the terms of applicable plans or agreements and is subject to Capgemini’s discretion, consistent with applicable laws. The Company reserves the right to amend or withdraw compensation programs at any time, within the limits of applicable legislation.**Disclaimers**Capgemini is an Equal Opportunity Employer encouraging inclusion in the workplace. Capgemini also participates in the Partnership Accreditation in Indigenous Relations (PAIR) program which supports meaningful engagement with Indigenous communities across Canada by promoting fairness, accessibility, inclusion and respect. We value the rich cultural heritage and contributions of Indigenous Peoples and actively work to create a welcoming and respectful environment. All qualified applicants will receive consideration for employment without regard to race, national origin, gender identity/expression, age, religion, disability, sexual orientation, genetics, veteran status, marital status or any other characteristic protected by law.This is a general description of the Duties, Responsibilities and Qualifications required for this position. Physical, mental, sensory or environmental demands may be referenced in an attempt to communicate the manner in which this position traditionally is performed. Whenever necessary to provide individuals with disabilities an equal employment opportunity, Capgemini will consider reasonable accommodations that might involve varying job requirements and/or changing the way this job is performed, provided that such accommodation does not pose an undue hardship. Capgemini is committed to providing reasonable accommodation during our recruitment process. If you need assistance or accommodation, please reach out to your recruiting contact.Please be aware that Capgemini may capture your image (video or screenshot) during the interview process and that image may be used for verification, including during the hiring and onboarding process.Click the following link for more information on your rights as an Applicant in the United States. http://www.capgemini.com/resources/equal-employment-opportunity-is-the-law