Validation Specialist

Position – Validation Specialist

Location – Sacramento California

Previous Experience – Must have experience in Qualification of sterile pharmaceutical facility

Company
Nivagen pharmaceuticals Inc. located in Sacramento CA is in the process of setting up a greenfield project for multiple sterile dosage forms such as vials, PFS, Cartridges, and IV Bags. Currently, all our products are being manufactured by a Contract Manufacturing company (CMO). Eventually, these products will be manufactured at the proposed facility. The Proposed facility is spread over 60,000 to 85000 Sq. Ft footprint which has manufacturing and packing functions along with Quality control Labs, R&D, and administration offices.

Overview
The Quality Validation Specialist will be responsible for the review, and participation in qualification activities to ensure the facility, equipment, and utilities get qualified for usage as per design. The expectation of this position, an individual will support the validation program by writing, executing, or providing oversight for detailed protocols and reports. Document the validation activities of the facility systems, equipment, and utilities in compliance with the appropriate regulatory agency validation requirements

This position will also participate in communicating validation activities during audits by customers and regulatory authorities. The position requires executing roles and responsibilities with minimal supervision and the ability to identify validation requirements and analyse and resolve the unique situations presented in the commissioning and qualification of a sterile injectable facility

Duties and Responsibilities

• Support IQ/OQ and/or PQ activities, re-qualification, enrolment or commissioning for the facility, HVAC systems, ISO 5, 6, 7 clean rooms, utilities, and equipment for sterile GMP manufacturing operation.
• Responsible for creating, updating, and maintaining associated documentation and reports relevant to the project.
• Anchor, execute and/or review validation documents such as change controls, validation project plans, validation protocols, validation reports, risk management tools, gap analysis, CAPA, and validation exceptions/deviations
• Schedule and execute validations as per standard operating procedures (SOP) and regulatory guidelines
• Participate in validation related investigations
• Champion and lead the continuous improvement efforts on every aspect of validation
• Assist with resolving the issues arising from internal quality assessments/audits, regulatory inspections, and notified body.
• Drive the efforts to close inspection issues, and findings by preparing appropriate responses and corrective actions.
• Foster cross-departmental relationships (QC, materials management, manufacturing, QA, and site leadership) by representing validation at team meetings
• Employ good documentation practices (GDP) when recording data, maintaining archives and drafting or reviewing documents
• Demonstrate technical expertise to define approaches and execution of system validation activities in accordance with cGMP, cGxP, CFR 21 Parts 11, 210, 211, ICH Q7, Q8, Q9 and applicable regulations and industry-standard procedures
• Use good engineering practice on assigned duties

Education
B.E / B. Tech – Mechanical/Chemical from reputed University OR Equivalent


Experience
Min 8 to 10 years of total professional experience in pharmaceutical facility validation and qualification in the following field

• Qualification of new facilities for Sterile Manufacturing and packing.
• Review and implementation of clean Utility qualification from scratch
• Review and execution of HVAC system for sterile Plants
• Basic Knowledge of Electrical, Instrumentation, and Process Engineering
• At least 5 years of relevant work experience in cGMP validation of facility, equipment utilities in, pharmaceutical or biotech industry
• Ability to work independently or with minimal managerial support
• Must have a working knowledge about cGMPs, International Society for Pharmaceutical Engineering (ISPE) guidelines, data integrity, 21 Code of Federal Regulations (CFR) Part 11 and Annex 11 regulations (electronic records and electronic signatures), industry good practices for Installation Qualification (IQ)/Operational Qualification (OQ)/Performance Qualification (PQ) and SOPs
• Requires strong interpersonal verbal communication and technical writing skills
• Strong technical background in the area of process, utilities, and engineering is preferred
• Working knowledge of industry regulations, standards, and baselines from FDA, EU-GMP, and WHO regulations, ISPE, or any other relevant regulatory agency
• Proven track record of audit preparation and readiness with quality, compliance, and safety
• Proven knowledge in the development, and verification of commissioning/qualification plans such as IOC, URS, FS, FAT, SAT, DQ, IQ, OQ, PQ, etc.
• Proven track record of applying GMP regulatory requirements and engineering best practices.
• Ability to manage priorities, deliverables, and schedule milestones

Competencies

Functional

• Knowledge of Sterile formulation engineering
• Knowledge of USFDA, cGMP, GLP, ISPE, ISO
• Project Management
• Planning & Execution o qualification activities

Behavioural

• Result oriented
• Innovative thinking
• Time Management
• Problem-solving ability & High level of self-motivation
• Strong interpersonal relationship skills
• Strong written & verbal communication