Lead Validation Consultant (Lab & Manufacturing)
About the Role
Techsol is seeking a Lead Validation Consultant who can provide expert-level strategic guidance to pharma, biotech, and medical device manufacturers for the commissioning, qualification, and validation of Labs and Manufacturing related software, equipment, instruments, critical utilities, facilities, GLP & GMP processes and applicable computer systems. The ideal candidate will be responsible for guiding internal team members to deliver high-quality validation services for clients to stay compliant with current GxP regulations.
- Provide subject matter expertise using the risk-based approach to plan, implement and validate software systems, instrumentation and equipment which will be used to manufacture new APIs, biologicals, and medical devices
- Complete GxP applicability assessments to ensure that labs and manufacturing related software systems and equipment are compliant to 21 CFR Part 11, EU Annex 11, HIPAA, and GDPR related data privacy and data integrity requirements
- Work with the client’s QA and Validation team and assist with the development of validation documentation such as Validation Master Plans (VMP), System Design Specifications (SDS), Users Requirements Specifications (URS), and Detailed Design Specifications (DDS).
- Provide guidance to team members for planning, authoring, executing, and documenting validation plans and associated Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols for equipment, systems, and processes.
- Perform deviation investigations, and execute duties related to the documentation and follow up to Corrective Preventative Action (CAPA) plans and Change Controls (CC).
- Assist in the preparation of FAT and SAT protocols, review validation outcomes and prepare closure documents such as qualification summary reports (QSR) and validation summary reports (VSR).
- Complete risk analysis and impact assessment for computer system change controls, validation findings, observations, and CAPAs
- Contribute towards the authoring and revisions of Standard Operating Procedures (SOPs) and related manufacturing process documentation.
- Prepare summary reports, deficiency/discrepancy reports, gap analysis, risk analysis, failure mode & effect analysis (FMEA), and traceability matrices.
- Review and approve Mapping/(Re) Qualification of Controlled Temperature Units such as Dryers, Ovens, Freezers and Warehouses.
- Ensure that the systems, utilities, and processes associated with manufacturing process remain in a validated state by reviewing the changes made throughout their validation life cycle.
- Responsible for creating validation projects and validation progress metrics /KPIs
- Ensure timely completion and compliance with cGMP and all other relevant company training requirements.
- Support inspection readiness programs and/or directly support regulatory agency inspections.
- Provide expertise for the investigation and complaint resolution of non-conformances encountered during (re)qualification/(re)validation activities and site unplanned events.
- Develop and evaluate quality processes and system standards to ensure compliance with applicable procedures, industry standards and global regulations.
Job Qualifications & Requirements
The ideal candidate for this job position is expected to meet the following requirements:
- Must have 8 to 10 years of proven work experience in commissioning, qualification, and validation of pharmaceutical systems, utilities, facility, and instrumentation that are used across GLP & GMP processes
- Should have a bachelor’s degree with a specialization either in Life Sciences, Industrial Engineering, biotechnology, chemistry, pharmacy with industry certifications related to GxP functional areas
- Hands-on experience in the validation and qualification of different types of manufacturing & processing equipment (batch processing, autoclave, lab instruments, etc.), storage containers (freezers, dryers, controlled environments, etc.), and software applications (LIMS, MES / MoM)
- Well versed in control system validation for process control systems (PCS), Building management systems (BMS), Environmental monitoring systems (EMS).
- Experience supporting enterprise software deployments and laboratory/manufacturing equipment and instruments (such as HPLC, MES, ERP, DMS, QMS, etc.)
- Knowledge and familiarity of various process equipment used in the pharmaceutical industry such as autoclaves, fillers, lyophilizers, pumps, vessels, mixers, etc.
- Must have practical knowledge in writing and execution of quality and validation documentation such as requirements, functional diagrams, IQ/OQ/PQ, SAT / FAT protocols, validation summary reports, etc.
- Strong knowledge in FDA cGMP guidelines, 21 CFR Part 11, EU Annex 11, HIPAA, GDPR, GAMP5, electronic records / electronic signatures, data integrity / data privacy requirements, global pharma standards and applicable regulatory guidelines.
- Knowledge of Good Clinical practice (GCP), Good pharmacovigilance Practice (GVP), Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Good Laboratory Practices (GLP).
- Thorough knowledge and ability to read and understand technical documentation such as mechanical drawings, P&I drawings, specifications, data sheets, etc.
- Knowledge and ability to use test instruments such as multimeters, tachometers, ammeters, pH meters, data loggers, etc. used during the validation process.
- Basic knowledge of PLC software and associated technical components
- Understanding of Biological Indicators, Temperature Mapping, Aseptic Techniques, EM and Smoke studies.
- Display good interpersonal and communication skills with team members and clients
- Ability to work in a dynamic team environment and work independently whenever required
Over the last 13+ years, Techsol Life Sciences has achieved remarkable growth and has earned a strong reputation as a leading services organization within the pharmaceutical industry. Through dedication, innovation, and a commitment to excellence, Techsol has established itself as a trusted partner for pharmaceutical and medical device companies seeking reliable and cutting-edge solutions. To know more about what we do, please visit www.techsollifesciences.com. Join us in our journey with your passion to develop a strong and committed workforce that excels in serving the pharma industry.