This role provides Manufacturing Execution Systems (Rockwell PharmaSuite) capabilities to the ITOT/MES Group, including generating qualification protocols and maintaining the validated state of systems.
Participate in Basic Design, Detailed Design, and Facility Startup, specifically focused on Recipe Authoring (Master Recipes/Workflows) and core system configuration.
Focuses on providing long-term lifecycle support for the newly built facility with respect to the manufacturing execution systems for process, utility, and building systems.
Lead the design and implementation of Recipe Authoring for drug product manufacturing processes in a GMP environment.
Support MES System implementation, including system architecture components and interfaces to partner systems (SAP, LIMS, Automation).
Act as the MES lead for equipment/software FAT, SAT, field testing, and commissioning.
Support plant operations to assess discrepant events, troubleshoot automation issues, and provide real-time on-floor support.
Execute or learn to execute system administration, user access management, and application performance monitoring.
Participate in a 24/7 on-call environment to meet business continuity requirements after the facility goes live.

Requirements

Bachelor’s or Master’s degree in Engineering (Chemical, Mechanical, Electrical, or Computer Science preferred).
Minimum of 5 years of applicable MES experience, preferably with a majority in drug product functions.
Direct experience in project execution followed by a transition into operational lifecycle support is highly preferred.
Deep expertise with MES System implementation and Recipe Authoring, specifically in the Rockwell PharmaSuite platform.
Demonstrated experience in providing long-term operational support, including patch management, system upgrades, and configuration control.
Ability to carry out or learn System Engineering responsibilities, including underlying database management (SQL), interface middleware, and server-level troubleshooting.
Knowledge of biopharmaceutical manufacturing, design, or construction, specifically in a Greenfield/Facility Startup environment.
Expert knowledge of Good Manufacturing Practices (GMP), 21 CFR Part 11, GAMP 5, and Data Integrity principles.
Knowledge of Manufacturing Execution Systems integration with enterprise systems such as SAP (Aspire), LIMS, and Data Historians.
Proven ability to produce and review critical design specification documents, including URS, PRS, FS, and DS.
Exhibits intellectual curiosity and a strong passion to bring value-adding technology to the business while partnering effectively with key stakeholders.

Benefits

A discretionary annual bonus may be available based on individual and Company performance.
Health insurance
Retirement plans
Professional development

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Manufacturing Execution SystemsRockwell PharmaSuiteRecipe AuthoringSystem AdministrationUser Access ManagementApplication Performance MonitoringSQLPatch ManagementSystem UpgradesConfiguration Control

Soft Skills

Intellectual CuriosityPassion for TechnologyStakeholder PartnershipTroubleshootingReal-time SupportProject ExecutionOperational Lifecycle SupportLeadershipCommunicationProblem Solving

Certifications

Bachelor’s Degree in EngineeringMaster’s Degree in EngineeringGMP CertificationGAMP 5 Certification21 CFR Part 11 Compliance Training