Senior QA Engineer, CSV/DI

Description

Join our dynamic Quality Assurance team as a Senior QA Engineer specializing in Computer System Validation and Data Integrity! This is an exceptional opportunity to lead the validation of cutting-edge GMP computer systems in a fast-paced, innovative CDMO environment. You'll work alongside a collaborative team of quality professionals who are passionate about ensuring patient safety through robust system validation and data integrity practices. As part of our growing organization, you'll have the opportunity to shape validation strategies from the ground up and make a meaningful impact on global pharmaceutical manufacturing.

As our Sr. QA Engineer, CSV/DI, you will provide expert oversight of computer system validation activities across all GMP systems including process automation, cloud-based platforms, and laboratory systems. You'll be responsible for developing and approving validation strategies, qualification protocols, and lifecycle documentation while ensuring compliance with FDA, EMA, and other global regulatory requirements. This role requires strong technical expertise, regulatory knowledge, and the ability to present confidently to client auditors and regulatory inspectors. You'll lead the implementation of risk-based validation approaches and ensure comprehensive documentation throughout the entire computer system lifecycle.

Essential Job Functions:

·            Computer System Validation Leadership for QA Team: Provide oversight and technical expertise for validation of all GMP computer systems including manufacturing execution systems (MES), laboratory information management systems (LIMS), process automation systems, and cloud-based applications

·            Strategy Development: Review, and approve computer system validation strategies, risk assessments, and validation master plans ensuring alignment with regulatory requirements and industry best practices

·            Documentation Management: Oversee creation, review, and approval of validation protocols, test scripts, validation reports, and other lifecycle documentation ensuring completeness and regulatory compliance

·            Risk-Based Validation: Implement and maintain risk-based validation approaches using GAMP 5 principles and ensure appropriate validation activities based on system criticality and complexity

·            Data Integrity Oversight: Ensure data integrity principles (ALCOA+) are embedded in all computer system designs, validations, and operations throughout the system lifecycle

·            Regulatory Interaction: Present validation strategies, documentation, and system compliance status to FDA, EMA, and other regulatory inspectors during audits and inspections

·            Client Engagement: Interface with client auditors to demonstrate system validation status, respond to technical queries, and ensure client confidence in our validation processes

·            Change Control: Oversee change control processes for validated systems ensuring appropriate impact assessments, testing, and documentation are completed

·            Vendor Management: Evaluate and qualify system vendors, review vendor documentation, and ensure appropriate vendor oversight throughout the system lifecycle

·            Training and Mentoring: Provide technical guidance and mentoring to junior validation staff and cross-functional teams on CSV and data integrity requirements

·            Continuous Improvement: Identify opportunities to enhance validation processes, implement industry best practices, and drive efficiency improvements while maintaining compliance

·            Cross-Functional Collaboration: Work closely with IT, Manufacturing, Quality Control, and other departments to ensure seamless integration of validation activities with business operations

Special Job Requirements:

·            Bachelor's degree in Engineering, Computer Science, Life Sciences, or related technical field

·            5+ years of experience in computer system validation within pharmaceutical, biotech, or medical device industries

·            Minimum 3+ years of experience presenting to regulatory inspectors (FDA, EMA) and client auditors

·            Strong knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and data integrity guidelines

·            Experience with validation of manufacturing execution systems (MES), LIMS, process automation, and cloud-based systems

·            Excellent written and verbal communication skills with ability to present technical information to diverse audiences

Additional Preferences:

• Advanced degree in relevant technical field
• Professional certifications in computer system validation or quality assurance
• Experience with CDMO operations and client-facing roles
• Knowledge of other international regulatory requirements (WHO, Health Canada, TGA)
• Experience with emerging technologies such as cloud computing, artificial intelligence, and advanced analytics in GMP environments

Additional info about INCOG BioPharma Services:

At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.

If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.

INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.  All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.

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