Verified Job
Lab Technician / Pharmacist
Lead consultant Smart Manufacturing Pharma
Lab Technician / Pharmacist
#49972
Remote / WFH
Capgemini Invent
Job Description
Role - Lead consultant Smart Manufacturing-Pharma
Location: PAN India
We are looking for a Lead Consultant – Smart Manufacturing with strong Pharma & Life Sciences experience to lead digital transformation across Manufacturing, Quality, and QC Labs. The role follows a sell–deliver–sell model, spanning opportunity shaping, proposal development, delivery across MES/eBR, LIMS, QMS, IT/OT, and AI, and expansion through value realization. The candidate should have proven experience delivering programs in regulated GxP environments, with strong understanding of compliance, data integrity, validation, audit readiness, and electronic records/signatures requirements.
Key Responsibilities and expectations (must have)
• Presales & Opportunity Shaping: Lead discovery workshops to shape problem statements, value cases, target architecture, and transformation roadmaps for pharma manufacturing.
• Proposal / RFP Leadership: Own proposal response strategy, solutioning, estimation, delivery approach, risk assumptions, pricing inputs, and develop reusable POVs/demos. Excellent storyboarding, value articulation, case writing, assumptions/risks/dependencies, and capability of creating executive-ready decks is mandatory.
• Estimation & planning: Lead delivery estimation and planning across work breakdown, resourcing, timelines, delivery model, and quality gates
• Commercial acumen: Good understanding of SOW constructs, milestones, governance, and input to pricing/commercials (with appropriate internal support).
• Client Advisory: Act as trusted advisor by bringing strong consulting capabilities, and proven delivery methodologies to influence decision-making through executive communication and structured recommendations.
• Program Leadership: Own multi-workstream delivery governance across sites; manage stakeholders, vendors and distributed teams.
• MES / eBR Leadership: Drive paperless manufacturing—requirements and solution design across eBR/eMBR, recipe/batch execution, materials & genealogy, weigh & dispense, and exceptions handling.
• LIMS / QC Digitization: Lead lab transformation—sample lifecycle, test workflows, stability, reporting/COA—and standardize QC processes and data models.
• Digital Quality (eQMS/QMS): Lead deviations, CAPA, change control, audits, training, document control and supplier quality digitization with audit-ready workflows.
• IT/OT & Data Architecture: Define integration blueprints across MES, ERP, LIMS, QMS, Historian, and SCADA, with contextualized data architecture for end-to-end traceability
• AI Enablement: Identify and lead AI/advanced analytics use cases (deviation insights, drift detection/predictive quality signals, process optimization, reliability analytics) with governance, traceability and controlled rollout.
Required Experience & Qualifications
• 10–14 years in Pharma/Life Sciences manufacturing digitalization with consulting delivery leadership.
• Bachelor’s/master’s in engineering/technology/industrial/Pharma/Chemical or related fields
• MBA or an equivalent qualification from a top tier/reputed institute.
• Strong experience across at least two of MES/eBR, LIMS, or eQMS/QMS, with integration/data platform exposure; Pharma MES experience (Werum PAS-X, PharmaSuite, Opcenter Pharma) is a plus
• Experience of managing discussions with clients, CXO level engagements, advisory roles.
Preferred / Nice to Have
• Exposure to ISA-95/ISA-88, MESA standards, manufacturing data contextualization, IIoT/historian integrations.
• Experience with cloud data platforms, MLOps concepts, and model monitoring/governance in regulated settings.
• Agile delivery (Scrum/SAFe), Lean/Six Sigma; alliance/vendor ecosystem experience; building demos/POVs.
• AI enablement experience: delivered/led 1–2 analytics/AI initiatives (PoC/MVP/scale) in manufacturing/quality contexts.
• Work Model Hybrid with site travel during key phases (workshops/go-live/hypercare); travel typically 10–40%.
Location: PAN India
We are looking for a Lead Consultant – Smart Manufacturing with strong Pharma & Life Sciences experience to lead digital transformation across Manufacturing, Quality, and QC Labs. The role follows a sell–deliver–sell model, spanning opportunity shaping, proposal development, delivery across MES/eBR, LIMS, QMS, IT/OT, and AI, and expansion through value realization. The candidate should have proven experience delivering programs in regulated GxP environments, with strong understanding of compliance, data integrity, validation, audit readiness, and electronic records/signatures requirements.
Key Responsibilities and expectations (must have)
• Presales & Opportunity Shaping: Lead discovery workshops to shape problem statements, value cases, target architecture, and transformation roadmaps for pharma manufacturing.
• Proposal / RFP Leadership: Own proposal response strategy, solutioning, estimation, delivery approach, risk assumptions, pricing inputs, and develop reusable POVs/demos. Excellent storyboarding, value articulation, case writing, assumptions/risks/dependencies, and capability of creating executive-ready decks is mandatory.
• Estimation & planning: Lead delivery estimation and planning across work breakdown, resourcing, timelines, delivery model, and quality gates
• Commercial acumen: Good understanding of SOW constructs, milestones, governance, and input to pricing/commercials (with appropriate internal support).
• Client Advisory: Act as trusted advisor by bringing strong consulting capabilities, and proven delivery methodologies to influence decision-making through executive communication and structured recommendations.
• Program Leadership: Own multi-workstream delivery governance across sites; manage stakeholders, vendors and distributed teams.
• MES / eBR Leadership: Drive paperless manufacturing—requirements and solution design across eBR/eMBR, recipe/batch execution, materials & genealogy, weigh & dispense, and exceptions handling.
• LIMS / QC Digitization: Lead lab transformation—sample lifecycle, test workflows, stability, reporting/COA—and standardize QC processes and data models.
• Digital Quality (eQMS/QMS): Lead deviations, CAPA, change control, audits, training, document control and supplier quality digitization with audit-ready workflows.
• IT/OT & Data Architecture: Define integration blueprints across MES, ERP, LIMS, QMS, Historian, and SCADA, with contextualized data architecture for end-to-end traceability
• AI Enablement: Identify and lead AI/advanced analytics use cases (deviation insights, drift detection/predictive quality signals, process optimization, reliability analytics) with governance, traceability and controlled rollout.
Required Experience & Qualifications
• 10–14 years in Pharma/Life Sciences manufacturing digitalization with consulting delivery leadership.
• Bachelor’s/master’s in engineering/technology/industrial/Pharma/Chemical or related fields
• MBA or an equivalent qualification from a top tier/reputed institute.
• Strong experience across at least two of MES/eBR, LIMS, or eQMS/QMS, with integration/data platform exposure; Pharma MES experience (Werum PAS-X, PharmaSuite, Opcenter Pharma) is a plus
• Experience of managing discussions with clients, CXO level engagements, advisory roles.
Preferred / Nice to Have
• Exposure to ISA-95/ISA-88, MESA standards, manufacturing data contextualization, IIoT/historian integrations.
• Experience with cloud data platforms, MLOps concepts, and model monitoring/governance in regulated settings.
• Agile delivery (Scrum/SAFe), Lean/Six Sigma; alliance/vendor ecosystem experience; building demos/POVs.
• AI enablement experience: delivered/led 1–2 analytics/AI initiatives (PoC/MVP/scale) in manufacturing/quality contexts.
• Work Model Hybrid with site travel during key phases (workshops/go-live/hypercare); travel typically 10–40%.
