Quality Validation Specialist

​​About the Role:

The Quality Validation Specialist will be responsible for the review and participation in qualification activities to ensure the facility, equipment, and utilities are 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 analyze and resolve the unique situations presented in the commissioning and qualification of a sterile injectable facility

You Will:

• 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

You Have:

• B.E / B. Tech – Mechanical/Chemical from reputed University OR Equivalent
• Minimum of 3-5 years of total professional experience in pharmaceutical facility validation and 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

Our Benefits (there are more but here are some highlights):

• Competitive salary & equity compensation for full-time roles
• Unlimited PTO, company holidays, and quarterly mental health days
• Comprehensive health benefits including medical, dental & vision, and parental leave
• Employee Stock Purchase Program (ESPP)
• Employee discounts on hims & hers & Apostrophe online products
• 401k benefits with employer matching contribution
• Offsite team retreats

Conditions of Employment: 

• This position will require working with Hazardous Drugs (HD) and would require that Personal Protective Equipment (PPE) be worn for the length of working with these drugs. These items would include gloves, respiratory protection, gown and other items as required.
• This position requires medical approval to wear respiratory protection in the form of negative or positive pressure respirators, including N95, full face respirator, SCBA, or Powered Air Purifying Respirator (PAPR).
• Physical exertion required. Including, but not limited to, walking up to 50% of the time, standing up to 100% of the time, squatting and bending up to 20% of the time and lifting up to 80% of the time for up to a twelve hour shift. Must be able to lift up to 50lbs.
• Due to the risk of reproductive capability in handling or compounding certain Hazardous Drugs (HD) associates must be willing to confirm that they understand the potential risks (teratogenicity, carcinogenicity and reproductive effects) of handling hazardous drugs.