QA Validation Engineer

The Fountain Group; Thousand Oaks (CA); On-site; USD 91,000 - 109,000; Full time

Job summary

The Fountain Group is seeking a QA Validation Specialist for a 6-month contract onsite in Newbury Park, Thousand Oaks, CA. You will lead cross-functional reviews of validation deliverables, ensuring compliance with SOPs, regulatory expectations, and data integrity across facilities, utilities, equipment, and computerized systems.

Ideal candidates have 5+ years in pharma/biopharma validation, strong IQ/OQ/PQ/CSV experience, and proficiency with Veeva, Kneat, and ALM.

Qualifications

• Bachelor's degree in biotech/related field.
• 5+ years in pharma/biopharma manufacturing.
• Experience with IQ/OQ/PQ/CSV and validation.
• Experience writing and executing validation protocols.
• Proficient in electronic document management systems (Veeva, Kneat, ALM).

Responsibilities

• Review validation documents for accuracy and compliance with SOPs and regulatory requirements.
• Review validation packages to support project development and regulatory submissions.
• Approve documents related to system validation and decommissioning.
• Provide QA support for facility, utilities, systems, processes and computerized systems.
• Contribute to risk assessments and ensure traceability across the project life cycle.
• Support GMP compliance and communicate risk trends to project timelines.

Skills

GxP knowledge

Quality oversight

Regulatory compliance

Documentation management

Education

Bachelor's Degree in Biotechnology, Microbiology, Pharmacy or equivalent

Tools

Veeva

Kneat

ALM

Job description

Details for the positionare as follows:

• 6-month contract to start with the possibility of extension or conversion depending on performance and business needs
• Rate: $66-79. 31 an hour
• Location: Newbury Park (Thousand Oaks), CA - 100% onsite

Job Description:

• Will work as part of cross-functional teams providing quality oversight, review, and approval of validation deliverables and change controls to ensure that products and processes meet appropriate regulatory agency validation requirements, internal company standards and current industry practices. This position will typically focus on disciplines related to facilities, utilities, equipment, instruments, process qualification, cleaning, computer systems validation and data integrity.
• Duties and Responsibilities
• Responsible for reviewing validation documents, against Standard Operating Procedures (SOPs) for accuracy and compliance with procedures, based on regulatory requirements and internal guidelines.
• Review from a quality perspective the validation documentation required to assure the proper development of a project and support regulatory submissions.
• Responsible for reviewing Validation Master Plans, Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification, Computer System Validation, and Validation Maintenance packages in accordance with existing procedures. Reviews deliverables for compliance with existing requirements. Approves documentation related to system decommissioning.
• Provide validation expertise and support for the development (or modification phases) of manufacturing facility, utilities, systems, process and information and Computerized System; address, include and implement all the applicable QA requirements.
• Participate in the risk assessment related to the project.
• Assure requirements traceability throughout the whole project life cycle.
• Provide support in all quality-related issues, including GMP regulations
• Maintain project metrics to communicate risk trends and implementation readiness to support project timelines and commercial readiness

Required Skills:

• Bachelor's Degree in Biotechnology, Microbiology, Pharmacy or equivalent.
• At least 5 years of experience in Pharmaceutical, Biopharmaceutical or related manufacturing environment, or an advanced degree.
• Strong experience with Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification, Computer System Validation, and Validation
• Experience in pharmaceutical/biotech validation which includes the writing and executing of protocols.
• Proficiency in electronic document management systems (e.g. Veeva, Kneat, ALM)