Brian Parry

Validation Professional targeting leadership positions (Manager/Director) or senior-level individual contributor that will utilize my technical, consulting and management skills to drive validation projects to completion and improve project / department efficiency for employer.  Over 30 years experience in Commissioning / Qualification / Validation of equipment, utility and facility systems and processes used in the manufacturing / packaging / shipping of pharmaceutical, biotech, medical device and diagnostic products.  Skills and accomplishments include:

• Management of Validation functional areas and projects, including direct supervision and training/mentoring of employees and contractors.
• Establishing and improving validation lifecycle approach to make Validation program(s) intuitive, adaptable and defendable, and to harmonize operations of Validation functional areas and stakeholder departments.  Collaborated with Quality Assurance to improve Quality Manual and quality procedures to align with validation improvements.
• Preparation and revision of Validation Master Plans (VMPs), qualification procedures, and document templates for qualification / validation / requalification activities.
• Development of Engineering Checkout / Commission programs for documenting installation / setup / startup / commissioning activities to ensure essential elements supporting fitness for intended use are appropriately verified and leveraged for qualification purposes. Worked with Engineering in identifying commissioning gaps and developing Good Engineering Practices to fulfill business and Validation needs.
• Extensive experience in qualifying steam sterilizers, steam-in-place systems and controlled temperature environments.
• Troubleshooting and resolving equipment / utility / facility issues encountered during qualification / requalification.
• Documenting validation expectations and vendor deliverables, and ensuring that these are effectively communicated and documented in contractually binding agreements.
• Fostering communication and camaraderie between Validation functional areas and stakeholder departments.

Open to new employment opportunities that will utilize my Validation, Commissioning, and Quality Systems experiences, and commitment to excellence and continuous quality improvement.

2019 to 2026 - Principal Validation Engineer, Manufacturing/Validation at Grifols Diagnostic Solutions, Emeryville CA:

• Improved existing Validation Master Plans (VMPs) and qualification procedures for commercial and clinical products.
• Collaboratively worked with Quality Assurance and other stakeholders to make improvements in the validation program to ensure that essential elements for establishing and maintaining the qualified state of GMP systems, processes and shipping of product are appropriately verified / tested and documented to meet company and regulatory requirements.
• Qualification / validation / requalification of controlled temperature environments (CTEs), sterilization processes, fermentation / purification / technical services equipment, utilities, facilities and shipping, including preparing and maintaining document templates for these activities.
• Led risk assessment projects associated with leveraging vendor / other Grifols’ sites qualification documentation for establishing qualified state of new shipping containers / configurations for product shipments from the Emeryville site, resolving a FDA observation for qualification of transporting temperature-controlled materials within the Emeryville site, and implementation of new autoclave load items without cycle development testing.  Led gaps assessments and VMP / SOP improvements (including Quality, Manufacturing, and Shipping procedures) to implement risk assessment actions.
• Collaborated with System Owners to improve SOPs to control operation of systems within their qualified state.
• Performed responsibilities associated with change control, validation procedural changes for internal / external audit finding response / resolution, and maintaining job safety.
• Provided guidance and mentoring for Validation personnel on setup and qualification of equipment, sterilization, utility and facility systems.  Created job aids, descriptive diagrams, safety plans, etc to facilitate personnel learning and safety.
• Prepared metric information on department performance used for management review.
• Resolved setup, commissioning, qualification, operation and use issues with cell bank LN2 freezers.
• Provided support for internal, corporate and regulatory inspections. 
• Provided support for cleaning validation / verification projects.
• Provided on-site support for various qualification projects at Grifols’ San Diego facility.

2014 to 2019 - Sr. Principal Engineer, Engineering/Quality Unit Validation at Bayer, Berkeley CA:

• Maintained Validation Master Plans for Commercial Products and the Berkeley Supply Center.
• Collaboratively worked with Quality Assurance Validation to make improvements in the validation program, documenting user requirements, and the commissioning / qualification / requalification process of equipment to ensure that essential elements for supporting and maintaining the qualified state of GMP systems and processes are appropriately captured.  Led effort to rework the periodic review process for all Validation functional areas at the Berkeley Supply Center.
• Validation / qualification / requalification (including validation periodic review) of controlled temperature environments (CTEs) and sterilization processes.
• Established validation approach for a two-phase project to implement Ellab datalogger systems at the Berkeley and Emeryville sites.  Worked with Ellab, Bayer IT and computer validation consultants to setup system with local SQL databases and resolve technical issues.  Worked with Quality Assurance Computer Systems group and consultants to generate and approve system qualification and lifecycle documentation (i.e. User Requirement Specification, Software Design Specification, Risk Assessment, Installation/Operational Qualification Protocols, Traceability Matrix, System SOP, etc).  Led project, managed change control, and successfully validated and released first-in-family system. Setup procedural training and performed OJT training for Users and System Administrators.
• Prepared and maintained document templates for validation periodic review, qualification and requalification of CTEs, sterilizers, and sterilization processes.
• Performed responsibilities associated with change control, validation procedural changes (including gap analysis and alignment with corporate procedures), manufacturing procedural changes to ensure control of equipment validated state, internal/external audit finding response / resolution, and maintaining job safety.
• Created and maintained the Berkeley Validation Sharepoint Site for cross-functional collaboration between all Validation groups, Quality Assurance, Quality Control and Manufacturing departments for validation program improvements, system / process related projects, and for sharing of validation templates, job aids, job safety information, and group training requirements.
• Provided guidance and mentoring for Validation and Engineering personnel on setup / qualification of CTEs and sterilization systems.  Created job aids, descriptive diagrams, etc to facilitate personnel learning. Provided guidance for resolving setup, operation and use issues with cell bank LN2 freezers.
• Reviewed and approved (as a Quality representative) equipment / utility maintenance and calibration plans and task lists in SAP.
• Harmonized and removed unnecessary training requirements for the Quality Unit Validation department. 
• Cross-functionally trained by Compliance group to assist in vendor audit at Steris manufacturing facility in Mentor, Ohio.

2011 to 2014 - Sr. Principal Engineer, Quality Engineering/Validation at Baxter, Hayward CA:

• Supervisor for up to four validation personnel in biologics and medical device validation.
• Identified and implemented improvements for project management, validation approach and documentation in the QE/Validation department, and ensuring control of validated systems.
• Reported project status and justified validation support issues to senior management, including obtaining cross-functional consensus on project prioritization and support associated with priority. 
• Collaboratively worked with Engineering to make improvements in documenting user requirements and the commissioning process to ensure that essential elements for supporting fitness for intended use are appropriately captured.
• Validation / qualification / requalification of facilities and utilities, and biologic and medical device manufacturing equipment, processes and shipping.
• Performed responsibilities associated with change control, procedural changes (including improvements to manufacturing SOPs to ensure control of equipment validated state), division compliance, internal/external audit findings, analysis of process failures, medical device complaint investigations and validation response / resolution to manufacturing crisis issues.
• Provided support for internal, corporate and regulatory inspections.

2009 to 2011 - Sr. Validation Specialist at Total Validation Services (a validation contracting firm):

• Contracting at Bayer Healthcare in Berkeley, CA.
• Preparation and implementation of Change Control Requests, Testing Requirements & Acceptance Criteria documents, Site Verification Test Protocols, and Turnover Packages in support of the Bayer site improvement project for rFVIII-PF.
• Validation of HVAC / facilities.
• Verification / qualification of process equipment and robotic vial labeling / packaging equipment.

2008 to 2009 - Sr. Manager, Technical Operations Validation (Equipment, Computerized Instruments, Utilities, Facilities, and Shipping) at ZymoGenetics, Seattle WA:

• Improved ZymoGenetics’ validation lifecycle approach and documentation hierarchy (Quality Policy Manual down to SOPs) in order to make the validation program intuitive, adaptable and defendable, and to harmonize operations of the various validation functional areas.
• Led effort in identifying and closing validation program gaps, and initiated development of Good Engineering Practices to fulfill business and validation needs.
• Initiated development of an Equipment Checkout program for documenting installation / setup / startup / commissioning activities to ensure that essential elements for supporting fitness for intended use are appropriately captured.
• Technical expert for validation issues associated with CMO production and shipping of Recothrom.
• Planned future improvements to the equipment requisition process in order reduce potential for redundant equipment purchases, and to ensure that validation expectations and deliverables are effectively communicated to vendors and are documented in contractually binding agreements.
• Re-established communication and camaraderie between the validation functional areas.
• Provided support for FDA and EU QP inspections.
• Performed management responsibilities per job description.

2006 to 2008 - Sr. Manager, Validation (Equipment, Computerized Instruments, Utilities, and Facilities) at PDL Biopharma, Fremont and Redwood City CA:

• Coordinated the revision of corporate GLP / GCP validation policy in order to allow innovative approaches similar to ASTM E2500-07 and GAMP 5 and changing Quality Assurance Validation’s role from an approving to reviewing capacity for GLP validation.
• Created / revised Validation Master Plans and procedures to ensure effectiveness of new approaches and efficiency of validation projects.
• Coordinated transition of the GLP equipment / utility validation group from Quality to Corporate Services in order to improve integration of Engineering / Maintenance / Metrology activities as part of the validation lifecycle approach.
• Worked with Engineering in identifying commissioning gaps and developing Good Engineering Practices to fulfill business and validation needs.
• Created an equipment validation consortium to determine where harmonization was needed between the California Research / Development and Minnesota Manufacturing facilities and where activities needed to be distinctly different with separate procedures.
• Educated non-Validation employees on basic principles of validation, differences between PDL’s GMP and GLP validation programs, and current philosophy and operations of the GLP equipment / utility validation group.
• Devised an Equipment Checkout program for documenting installation / setup / startup / commissioning activities to ensure that essential elements for supporting fitness for intended use (and reducing the validation effort) are appropriately captured.
• Ensured that User Requirement Specification documents were created for critical systems and improved how requirements / specifications are documented in order to ensure validation efficiency.
• Participated with Engineering and Purchasing during the Request for Proposal and vendor selection process.  Communicated with proposed vendors on documentation requirements to support validation.
• Created new equipment / utility system assessment process to determine/document if a system will be used for GxP activities and requires qualification, ensure that requirements and specifications are appropriately documented, identify potential risks, establish traceability between validation and non-validation documentation, and document rationale for qualification approach and lifecycle.
• Managed the change control and requalification process for the relocation of 100+ qualified equipment to new corporate headquarters in Redwood City and the removal of qualified status for 50+ equipment.
• Closed out the validation program as part of company restructuring effort in 2008.
• Performed management / project management responsibilities per job description.
• Responsible for training personnel on various Validation practices.
• Attended ISPE Conference in Tampa, FL for GAMP 5 Launch during Feb 2008.
• Attended SQA Conference in Austin, TX during May 2007.
• Attended ISPE training in Atlanta, GA during May 2006.
• Baseline Guide for Practical Application of Commissioning and Qualification.
• Biopharmaceutical Manufacturing Facilities (Design, Commissioning and Qualification).

1996 to 2006 - Sr. Validation Specialist at Bänziger Systems (a validation contracting firm):

• Clients included Aerojet Fine Chemicals, Alza, Bayer, Banner Pharmacaps, BioMarin, BioRad, Catalytica Pharmaceuticals, Chemrich, Chiron, Impax Pharmaceuticals, Large Scale Biology, MedImmune, Nektar Therapeutics, Pharmavite, and Sierra Diagnostics.
• Project management, including sales / project bidding, supervision of up to six personnel and monitoring project budget/timelines.
• Trained new employees.
• Developed validation programs for clients by establishing Validation Master Plans and core SOPs identifying basic validation approach, terminology, documentation requirements, and procedures.
• Preparation of Validation Master Plans for individual systems and multi-system projects.
• Developed Turnover Package (TOP) / Commissioning Package programs to ensure proper installation / operation of equipment / utility systems and to improve validation efficiency.
• Performed Engineering Checkout / Site Acceptance Testing and prepared TOPs.
• Reverse engineering of complex manufacturing systems to develop protocols for Operational and Performance Qualification test work.
• Validation of clean utility systems (i.e., purified water, clean steam, gases), CIP systems, and HVAC / facilities.
• Qualification/Validation of process and process support equipment: steam sterilizers, lyophilizers, process chromatography systems, tablet presses, tablet coaters, tablet laser drilling equipment, fluid bed granulators, ultra-filtration systems, reactors, encapsulation machines, mixing/blending/milling equipment, dryers, fillers, sealers, cutters, labeling equipment, isolation units and bio-safety cabinets.
• Software/control system validation for tablet testers, in-process scale data acquisition equipment, labelers, purified water systems, chromatography skids, tablet laser drills, and fluid bed granulators.
• Temperature monitoring/analysis of thermal storage and shipping equipment: freezers, cold rooms, refrigerators, incubators, stability chambers, and cold-storage shipping containers.
• Temperature monitoring/analysis of thermal processing equipment, including heat penetration studies: lyophilizers, dry heat ovens, and steam sterilizers.
• Prepared and executed process qualifications in support of scale-up operations and transferring processes to new facilities/equipment.
• Cleaning validation for automated CIP systems.
• Shipping validation: configuration development, protocol preparation and execution.
• Troubleshooting of complex equipment and utility systems in order to improve operation.
• Setup, operation and training for Validator 2000 and other datalogger systems.

1996 - Validation Technician (independent sub-contractor at Chiron Corporation):

• Installation / Operational Qualification of freezers, refrigerators, steam sterilizers, and glassware washers.
• Performance Qualification of lyophilizers, dry heat ovens, steam sterilizers, and stopper washers.
• Cleaning validation for manual cleaning of tanks and filling equipment.
• Shipping validation: configuration development, protocol preparation and execution.

B.S. in Environmental Biology and Management, 1995, University of California at Davis.
Course work in Engineering, Statistics, Biology, Environmental Toxicology, and Federal Regulations.