Lead Recipe Authoring - MES (Syncade) GMP

Cognizant; Bridgewater (MA); On-site; USD 70,000 - 130,000; Full time

Benefits offered by this job

Medical/Dental/Vision/Life Insurance

Paid holidays plus PTO

401(k) plan and contributions

Long-term/Short-term Disability

Paid Parental Leave

Employee Stock Purchase Plan

Job summary

Cognizant is seeking a seasoned MES expert to lead Recipe Authoring within Emerson Syncade for a new manufacturing execution system implementation in a regulated pharma/biotech setting. The role demands strong experience in RA/configuration and strict GxP documentation practices.

You will collaborate with process engineering, automation, QA, and manufacturing to translate requirements into validated MES recipes and ensure compliance with 21 CFR Part 11 and GAMP 5 throughout the project lifecycle.

Qualifications

• 7+ years MES experience with 4+ years Syncade RA/config in regulated pharma/biotech.
• Strong GxP documentation exposure.
• Excellent stakeholder communication skills.

Responsibilities

• Lead end-to-end Recipe Authoring (RA) activities within Emerson Syncade MES for a new manufacturing execution system implementation.
• Design, configure, and author master batch recipes, process orders, and electronic batch records (EBR) in Syncade, aligned to GMP and client SOPs.
• Partner with process engineering, automation (DeltaV/PLC), QA, and manufacturing teams to translate process requirements into validated MES recipes.
• Drive requirement gathering, gap analysis, and preparation of Functional Design Specifications (FDS) for recipe and workflow configuration.
• Ensure all recipe designs comply with 21 CFR Part 11, GAMP 5, and the client's computer system validation lifecycle (URS, FRS, DS, IQ/OQ/PQ).
• Act as key liaison with client stakeholders and cross-functional teams (Automation, IT, QA) to align on MES architecture and recipe strategy.
• Support unit, integration, and UAT testing for recipe/process order execution; troubleshoot issues and manage defect resolution through closure.
• Provide EST-aligned support coverage for project delivery, defect fixes, and go-live/hypercare — mandatory regardless of work location.
• Own and maintain technical documentation — recipe design documents, configuration specifications, test scripts, and change control records.

Skills

MES experience

Syncade RA/config

Stakeholder communication

GxP documentation

Tools

DeltaV

PLC

Job description

Cognizant is seeking a seasoned MES expert to lead Recipe Authoring within Emerson Syncade for a new manufacturing execution system implementation in a regulated pharma/biotech setting. The role demands strong experience in RA/configuration and strict GxP documentation practices.

You will collaborate with process engineering, automation, QA, and manufacturing to translate requirements into validated MES recipes and ensure compliance with 21 CFR Part 11 and GAMP 5 throughout the project lifecycle.