Sr Digital Operations Specialist 1

About the role

The Sr. Digital Operations Specialist 1 leads the design, configuration, validation, and sustainment of digital manufacturing systems (e.g., MES, data historians, electronic logbooks) in a cGMP environment. This role acts as the subject matter expert (SME) for one unit operation family (Upstream, Downstream, or Solutions).

Responsibilities

• Leads complex configuration, enhancement, and sustainment of digital tools (e.g., MES, data historians, e-logbooks) aligned to approved standards, recipe design, and master data;
• Owes changes through documented change control and governance;
• Serves as unit operations SME (e.g., Upstream, Downstream, or Solutions); owns recipe design standards, parameter models, equipment models, material master data, and EBR usability within the assigned domain;
• Authors, reviews, and approves technical documentation (e.g., URS, FS/DS, configuration specifications, test scripts, SOPs, standard work); facilitates cross-functional review and sign-off;
• Defines validation strategies and executes CSV activities (IQ/OQ/PQ) using risk-based approaches consistent with cGMP, ALCOA+, and GAMP 5; contributes to risk assessments and traceability;
• Maintains system performance, analyzes trends, and leads root cause investigations for high-complexity issues; implements robust CAPAs and preventative measures;
• Coordinates and manages integrations with adjacent systems (e.g., LIMS, ERP, DCS/PLC, historians), including interface specifications, testing protocols, data mapping, and troubleshooting;
• Owes technology transfer digital readiness and capability gap assessments for new clients/products: Conducts structured gap analyses between sending and receiving sites for MES objects/recipes, master data, equipment and parameter models, interface requirements, reporting, security/roles, archival/retention;
• Defines and tracks remediation plans (e.g., configuration, validation, training, SOPs, change controls) to close gaps prior to engineering/PQ runs and PPQ;
• Maps process parameters and data flows; aligns recipe design and material master data; authors/aligns URS and acceptance criteria for transfer-related changes;
• Covers technology transfer readiness and capability gap assessments for new clients/products: Conducts structured gap analyses between sending and receiving sites for MES objects/recipes, master data, equipment and parameter models, interface requirements, reporting, security/roles, archival/retention;
• Defines and tracks remediation plans (e.g., configuration, validation, training, SOPs, change controls) to close gaps prior to engineering/PQ runs and PPQ;
• Owns technology transfer digital readiness and capability gap assessments for new clients/products: Conducts structured gap analyses between sending and receiving sites for MES objects/recipes, master data, equipment and parameter models, interface requirements, reporting, security/roles, archival/retention;
• Defines and tracks remediation plans (e.g., configuration, validation, training, SOPs, change controls) to close gaps prior to engineering/PQ runs and PPQ;
• Owns technology transfer digital readiness and capability gap assessments for new clients/products: Conducts structured gap analyses between sending and receiving sites for MES objects/recipes, master data, equipment and parameter models, interface requirements, reporting, security/roles, archival/retention;
• Defines and tracks remediation plans (e.g., configuration, validation, training, SOPs, change controls) to close gaps prior to engineering/PQ runs and PPQ;
• Owns technology transfer digital readiness and capability gap assessments for new clients/products: Conducts structured gap analyses between sending and receiving sites for MES objects/recipes, master data, equipment and parameter models, interface requirements, reporting, security/roles, archival/retention;
• Defines and tracks remediation plans (e.g., configuration, validation, training, SOPs, change controls) to close gaps prior to engineering/PQ runs and PPQ;
• Owns technology transfer digital readiness and capability gap assessments for new clients/products: Conducts structured gap analyses between sending and receiving sites for MES objects/recipes, master data, equipment and parameter models, interface requirements, reporting, security/roles, archival/retention;
• Defines and tracks remediation plans (e.g., configuration, validation, training, SOPs, change controls) to close gaps prior to engineering/PQ runs and PPQ;
• Owns technology transfer digital readiness and capability gap assessments for new clients/products: Conducts structured gap analyses between sending and receiving sites for MES objects/recipes, master data, equipment and parameter models, interface requirements, reporting, security/roles, archival/retention;
• Defines and tracks remediation plans (e.g., configuration, validation, training, SOPs, change controls) to close gaps prior to engineering/PQ runs and PPQ;
• Owns technology transfer digital readiness and capability gap assessments for new clients/products: Conducts structured gap analyses between sending and receiving sites for MES objects/recipes, master data, equipment and parameter models, interface requirements, reporting, security/roles, archival/retention;
• Defines and tracks remediation plans (e.g., configuration, validation, training, SOPs, change controls) to close gaps prior to engineering/PQ runs and PPQ;
• Owns technology transfer digital readiness and capability gap assessments for new clients/products: Conducts structured gap analyses between sending and receiving sites for MES objects/recipes, master data, equipment and parameter models, interface requirements, reporting, security/roles, archival/retention;
• Defines and tracks remediation plans (e.g., configuration, validation, training, SOPs, change controls) to close gaps prior to engineering/PQ runs and PPQ;
• Owns technology transfer digital readiness and capability gap assessments for new clients/products: Conducts structured gap analyses between sending and receiving sites for MES objects/recipes, master data, equipment and parameter models, interface requirements, reporting, security/roles, archival/retention;
• Defines and tracks remediation plans (e.g., configuration, validation, training, SOPs, change controls) to close gaps prior to engineering/PQ runs and PPQ;
• Owns technology transfer digital readiness and capability gap assessments for new clients/products: Conducts structured gap analyses between sending and receiving sites for MES objects/recipes, master data, equipment and parameter models, interface requirements, reporting, security/roles, archival/retention;
• Defines and tracks remediation plans (e.g., configuration, validation, training, SOPs, change controls) to close gaps prior to engineering/PQ runs and PPQ;
• Owns technology transfer digital readiness and capability gap assessments for new clients/products: Conducts structured gap analyses between sending and receiving sites for MES objects/recipes, master data, equipment and parameter models, interface requirements, reporting, security/roles, archival/retention;
• Defines and tracks remediation plans (e.g., configuration, validation, training, SOPs, change controls) to close gaps prior to engineering/PQ runs and PPQ;
• Owns technology transfer digital readiness and capability gap assessments for new clients/products: Conducts structured gap analyses between sending and receiving sites for MES objects/recipes, master data, equipment and parameter models, interface requirements, reporting, security/roles, archival/retention;
• Defines and tracks remediation plans (e.g., configuration, validation, training, SOPs, change controls) to close gaps prior to engineering/PQ runs and PPQ;
• Owns technology transfer digital readiness and capability gap assessments for new clients/products: Conducts structured gap analyses between sending and receiving sites for MES objects/recipes, master data, equipment and parameter models, interface requirements, reporting, security/roles, archival/retention;
• Defines and tracks remediation plans (e.g., configuration, validation, training, SOPs, change controls) to close gaps prior to engineering/PQ runs and PPQ;
• Owns technology transfer digital readiness and capability gap assessments for new clients/products: Conducts structured gap analyses between sending and receiving sites for MES objects/recipes, master data, equipment and parameter models, interface requirements, reporting, security/roles, archival/retention;
• Defines and tracks remediation plans (e.g., configuration, validation, training, SOPs, change controls) to close gaps prior to engineering/PQ runs and PPQ;
• Owns technology transfer digital readiness and capability gap assessments for new clients/products: Conducts structured gap analyses between sending and receiving sites for MES objects/recipes, master data, equipment and parameter models, interface requirements, reporting, security/roles, archival/retention;
• Defines and tracks remediation plans (e.g., configuration, validation, training, SOPs, change controls) to close gaps prior to engineering/PQ runs and PPQ;
• Owns technology transfer digital readiness and capability gap assessments for new clients/products: Conducts structured gap analyses between sending and receiving sites for MES objects/recipes, master data, equipment and parameter models, interface requirements, reporting, security/roles, archival/retention;
• Defines and tracks remediation plans (e.g., configuration, validation, training, SOPs, change controls) to close gaps prior to engineering/PQ runs and PPQ;
• Owns technology transfer digital readiness and capability gap assessments for new clients/products: Conducts structured gap analyses between sending and receiving sites for MES objects/recipes, master data, equipment and parameter models, interface requirements, reporting, security/roles, archival/retention;
• Defines and tracks remediation plans (e.g., configuration, validation, training, SOPs, change controls) to close gaps prior to engineering/PQ runs and PPQ;
• Owns technology transfer digital readiness and capability gap assessments for new clients/products: Conducts structured gap analyses between sending and receiving sites for MES objects/recipes, master data, equipment and parameter models, interface requirements, reporting, security/roles, archival/retention;
• Defines and tracks remediation plans (e.g., configuration, validation, training, SOPs, change controls) to close gaps prior to engineering/PQ runs and PPQ;
• Owns technology transfer digital readiness and capability gap assessments for new clients/products: Conducts structured gap analyses between sending and receiving sites for MES objects/recipes, master data, equipment and parameter models, interface requirements, reporting, security/roles, archival/retention;
• Defines and tracks remediation plans (e.g., configuration, validation, training, SOPs, change controls) to close gaps prior to engineering/PQ runs and PPQ;
• Owns technology transfer digital readiness and capability gap assessments for new clients/products: Conducts structured gap analyses between sending and receiving sites for MES objects/recipes, master data, equipment and parameter models, interface requirements, reporting, security/roles, archival/retention;
• Defines and tracks remediation plans (e.g., configuration, validation, training, SOPs, change controls) to close gaps prior to engineering/PQ runs and PPQ;
• Owns technology transfer digital readiness and capability gap assessments for new clients/products: Conducts structured gap analyses between sending and receiving sites for MES objects/recipes, master data, equipment and parameter models, interface requirements, reporting, security/roles, archival/retention;
• Defines and tracks remediation plans (e.g., configuration, validation, training, SOPs, change controls) to close gaps prior to engineering/PQ runs and PPQ;
• Owns technology transfer digital readiness and capability gap assessments for new clients/products: Conducts structured gap analyses between sending and receiving sites for MES objects/recipes, master data, equipment and parameter models, interface requirements, reporting, security/roles, archival/retention;
• Defines and tracks remediation plans (e.g., configuration, validation, training, SOPs, change controls) to close gaps prior to engineering/PQ runs and PPQ;