Job Description
Discoverant Engineer / Consultant Pharmaceutical Client
Job Title
Discoverant Engineer / Consultant
Industry Domain
Pharmaceutical / Life Sciences (GxP-regulated Manufacturing)
Experience Required
5-10 years
Employment Type
Full-time
Location
Chennai//Kochi/Coimbatore - Hybrid
Role Overview
We are looking for an experienced Discoverant Engineer/Consultant to support a pharmaceutical manufacturing client on the design, configuration, development, and validation of an enterprise manufacturing intelligence and data review solution built on the Honeywell Discoverant platform. The candidate will work closely with manufacturing, quality, QC/laboratory, and validation teams to aggregate, trend, and analyze batch, process, and lab data from disparate source systems, delivering a GxP-compliant, scalable, and secure review-by-exception and investigation-support capability, from estimation and solution design through to build, testing, and qualification.
Key Responsibilities
- Design, develop, and configure Discoverant applications (Data Sources, Parameters, Groups, Worksheets, Reports) for cross-system manufacturing and laboratory data aggregation and analysis.
- Configure and maintain Discoverant connectors/adapters to source systems such as LIMS, process historians (e.g., AVEVA Historian, Ignition Tag Historian), MES/Batch systems, and ERP for automated data pull-through.
- Build standardized, template-driven Worksheets, trend charts, and statistical (SPC/CPK) reports to support batch release, review by exception, and continued process verification (CPV).
- Support integration between Discoverant and LIMS/MES/Historian/ERP systems commonly used in pharma manufacturing, ensuring accurate parameter mapping and unit/limit configuration.
- Prepare effort and cost estimations, solution architecture documents, and technical proposals for Discoverant implementation projects.
- Ensure solutions comply with GxP, 21 CFR Part 11 (electronic records/electronic signatures), and data integrity (ALCOA+) principles.
- Author and execute validation lifecycle documentation — URS, FRS/FDS, DQ, IQ, OQ, PQ, Traceability Matrix — in line with GAMP 5 methodology.
- Configure user roles, electronic signature workflows, security groups, and audit trail settings for high-integrity, high-availability operation.
- Collaborate with QC/laboratory, manufacturing IT, automation, and quality/validation teams to ensure seamless data flow and correct business-rule configuration.
- Conduct FAT/SAT, commissioning, and post-go-live support/troubleshooting at client site.
- Support change control, periodic review, and system revalidation activities per client quality procedures.
- Provide technical documentation, as-built configuration records, and knowledge transfer/training to client quality, manufacturing, and support teams.
Pharmaceutical / Regulatory Domain Expertise (Preferred)
- Sound knowledge of GAMP 5 computerized system validation (CSV/CSA) lifecycle and documentation practices.
- Working knowledge of 21 CFR Part 11, EU Annex 11, and data integrity (ALCOA+) requirements, along with review-by-exception and batch release workflows.
Certifications (Preferred)
- Discoverant certification/training.
- GAMP 5 / CSV training certification.
Soft Skills & Other Requirements
- Strong client-facing communication skills; ability to work directly with pharma quality, QC/laboratory, and manufacturing stakeholders.
- Ability to prepare and present technical estimations, proposals, and solution walkthroughs to client/hiring stakeholders.
- Strong documentation discipline suited to regulated/validated environments.
- Good analytical and troubleshooting skills for live production support and investigation scenarios.