Chris Patten

Remote contractor for CTG, Inc. (Evonik)

• Proved successful working within tight deadlines and a fast-paced environment.
• Conducted thorough document reviews to identify inaccuracies, inconsistencies, or areas needing clarification.
• Followed company policies and editorial guidelines to craft thorough, well-written content.
• Maintained consistency across company documents by adhering to established style guidelines and templates.
• Coordinated with subject matter experts to ensure the accuracy of technical content in documentation projects.
• Reviewed and edited technical documents for clarity, grammar, and accuracy before submission.
• Proofread copy written by colleagues to correct spelling, punctuation, and grammar.
• Edited and proofread technical documents for accuracy and consistency.

On-site contractor for CTG, Inc (Astra Zeneca)

• Qualified Heat Sealers for the packaging of components prior to sterilization (Support Services).
• Qualified Lighthouse Monitoring System for Production Facility (Environmental Monitoring).
• Qualified Laminar Flow Booth.
• Ensured regulatory compliance with meticulous documentation of all validation activities and results.
• Improved validation processes by implementing risk-based strategies and advanced techniques.
• Maintained a safe working environment by adhering to strict safety guidelines during all validation activities.
• Collaborated with cross-functional teams for identification and resolution of validation issues.
• Developed positive working relationships with stakeholders to effectively coordinate work activities.
• Achieved successful project outcomes by maintaining accurate documentation and meeting strict deadlines.

On-site Contractor for CTG, Inc (Sanofi-Pasteur)

(Requested Back by Sanofi); COVID-19 Booster – Biomedical Advanced Research and Development Authority (BARDA) Project
• Mentored junior team members, fostering a culture of knowledge-sharing and professional growth within the department.
• Wrote, reviewed, and edited technical documents in accordance with template requirements.
• Participated in formal internal design reviews of proposed products and components.
• Verified construction documentation to meet client requirements and vision.

On-site contractor for CTG, Inc. (Thermo-Fisher Clinical Services)

• Generation of packaging equipment Process Design document as part of New Product Introduction/Tech Transfer for Commercial production.
• Generation of Qualification Documents for Packaging Equipment (Induction Sealer, Capsule Filling Machine).
• Generation of Qualification Document for Hold Study (Expiry) of Packaged PUW.
• Established strong working relationships with clients through exceptional communication skills, fostering trust and collaboration.
• Improved client satisfaction with detailed progress reports and proactive communication during project execution phases.
• Trained and mentored junior engineers, providing guidance and direction.
• Met tight deadlines to satisfy client demands and project timelines.

On-site contractor for DPS Group Global (Celgene/Bristol Myers Squibb)

• Deviation Initiation/Investigation using eQRMS.
• Participated in the qualification of Biologics Clinical Processing Facility.
• Collaborated on Standard Operating Procedure (SOP) development, incorporating input from Production/ Operations team to reduce liability and enhance successful deployments.
• Authored validation protocols for Cell Culture production systems, verifying compliance with internal policies and external safety requirements.
• Performed detailed reviews of validation reports, identifying potential gaps or inconsistencies that could impact product quality or compliance.
• Established clear communication channels with stakeholders throughout the organization, promoting transparency during all phases of the validation lifecycle.
• Reviewed requirements, specifications, and technical design documents to provide timely and meaningful feedback.
• Monitored and reported on test results and performance data to identify areas of opportunity for improvement.
• Collaborated with cross-functional teams for identification and resolution of validation issues.
• Collaborated with other departments to facilitate successful project completion.

On-site contractor for DPS Group Global (Walter Reed Army Institute of Research)

• Commissioned Glassware/Parts Washers and Depyrogenation Ovens for new building.
• Wrote, reviewed, and edited technical documents in accordance with template requirements.
• Developed positive working relationships with stakeholders to effectively coordinate work activities.
• Maintained a safe working environment by adhering to strict safety guidelines during all validation activities.
• Improved client satisfaction with detailed progress reports and proactive communication during project execution phases.
• Ensured regulatory compliance with meticulous documentation of all validation activities and results.
• Met tight deadlines to satisfy client demands and project timelines.

On-site contractor for CTG, Inc (Sanofi-Pasteur)

(Extended from original contract)

• Commissioned/qualified (50L, 200L & 2000L) single-use reactor systems for production of vaccines (C-diff, meningitis).
• Commissioned/qualified parts washers.
• Qualified CIP system.
• Developed Test Script for modification to Vision & Labeling Systems on Packaging Line.
• Developed/generated robust testing documents that contributed to the commissioning and qualification of process equipment (SLIA, DR/DQ, FCCA, CTP, FAT, IOQ).
• Ensured regulatory compliance with meticulous documentation of all validation activities and results.
• Maintained an up-to-date understanding of relevant industry guidelines such as FDA regulations or GAMP standards to inform daily duties.
• Participated in ongoing professional development opportunities to maintain a cutting-edge understanding of validation methodologies and technologies.
• Reviewed technical drawings developed by CAD technicians and drafters.
• Verified construction documentation to meet client requirements and vision.
• Reviewed technical reports, demonstrating strong attention to detail and commitment to quality assurance standards.
• Maintained a safe working environment by adhering to strict safety guidelines during all validation activities.
• Met tight deadlines to satisfy client demands and project timelines.

On-site contractor for CTG, Inc (Centocor/Johnson & Johnson)
• Lead role for client’s Validation Department (Equipment).
• Generation of Qualification Documents for Parts Washers, Control Rate Freezers, Wave Bioreactors, and Portable Vessels.
• Qualification/Re-qualification of Parts Washers, Control Rate Freezers, Wave Bioreactors, and Portable Vessels.

On-site contractor for CTG, Inc (Centocor/Johnson & Johnson)
• Lead role for client’s Validation Department (Cleaning Validation).
• Generation of Qualification Documents for vessel/equipment CIP processes (DPC & Cell Culture).
• Qualification of vessel/equipment CIP processes (DPC & Cell Culture).
• Swab Sampling Qualified.

On-site contractor for CTG, Inc (Sanofi-Aventis)
• Generated URS’s that contributed to the commissioning and qualification of pre-clinical manufacturing equipment.
• Qualification of pre-clinical manufacturing equipment.
• Commissioning & Qualification of modifications to the BAS System and Facilities in Building GV25 Warehouse.