KEVIN P. JACKSON 1257 Hill Hollow Way Apex, NC 27523kpjack1974@hotmail.com Home (919) 290-2720 Cell (843) 616-0883____

Objective To obtain a challenging position that will provide further growth opportunities.

Education Central Carolina Community College Sanford, NC Bioprocess Technician Training (Boot Camp) January 2004

Francis Marion University Florence, SCBachelor of Science, Biology December 1997

Summary Trained and Qualified in cGMP with 13 years of pharmaceutical industry experience and service.• Extremely reliable, hard working, and honest.• Well-organized and thorough in completing projects.• Excellent oral, written communication and documentation skills.• Successful use of RCA (Root Cause Analysis) and CAPA processes during deviation and investigation

events.Employment Pfizer Sanford, N.C. History Bioprocess Technician IV 11/16-Present

• Purification manufacturing operations for CY and Defined media CRM195 carrier protein.

Employment Catalent Pharma Solutions Morrisville, N.C. History Lead Validation Engineer 05/16-11/16

• Main validation support for clinical and commercial manufacturing.• Review of site change controls for validation impact to qualified equipment and provide validation

deliverables as necessary.• Supervise validation contractor resources during drafting, execution and post execution validation

protocol activities. • Periodic Review of equipment for impact to validated state.

Employment Biogen Idec RTP, N.C. History Quality Control Associate II 12/14-05/16

• Lead the effort for the Draeger Aerotest Kit method qualification.• Lead effort of inspection and sampling of all incoming raw materials and components.• Lead the effort for the raw material qualification of HyClone 200L bioprocess container.• Lead the effort for the raw material qualification of the Satorius Stedim 20L bioprocess container.• Lead the effort for writing investigations, deviations (events and investigations) related to raw materials

activities.

Employment Kelly Services at Biogen Idec RTP, N.C. History Manufacturing Associate II 07/14-12/14

• Perform and document daily manufacturing operations in a cGMP environment that involves operation of process equipment, execution of validation protocols, revising cGMP documents, manufacturing support activities, monitor process against the batch record, SLR or control system and other assignments as directed.

Employment Wyeth / Pfizer acquisition Wyeth 11/09 Sanford, N.C. History Validation Specialist III 12/09-02/14

• Lead temperature mapping of cold temperature units.• Assist with HEPA filter recertification.• Led steam sterilization for fermentation vessels.

o Mentored contractor on equipment qualification and Kaye Validator.• Led investigation for cGMP process equipment events.

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KEVIN P. JACKSON 1257 Hill Hollow Way Apex, NC 27523kpjack1974@hotmail.com Home (919) 290-2720 Cell (843) 616-0883____

o Successfully closed 65 investigations in one year using RCA (Root Cause Analysis) and CAPA processes to prevent repeat events

• Drafted the equipment summary report section for regulatory filling for CRM optimization changes.• Led commissioning effort for HAMO parts washer installation verification.• Completed Requalification Evaluation of HVAC units.• Completed Validation Project Plan, enhanced commissioning, and leveraged IOQ qualification for six

portable 260L vessels.• Led Validation effort for four additional depth filter housings.• Led Validation effort for elution pump in small scale purification area.• Created and facilitated white board discussions for Site Engineering Maintenance (SEM) Central

Validation Group and SEM Operations Group.

Validation Specialist II 11/07-12/09• Completed Installation Operational Qualification (IOQ) for new Steris Finn Aqua Autoclave.• Led High Temperature Control (HTC) commissioning IV, OV activities.• Assisted in the drafting of the Validation Project Plan for CRM optimization.• Led steam qualification of the additional depth-filter housing.• Led Validation effort for three 250L portable vessel commissioning and IOQ qualification.• Led Validation effort for three 100L portable vessel commissioning and IOQ qualification.• Led Validation effort for 10K UF skid commissioning and IOQ qualification, including FAT activities,

providing feedback to the vendor for ETOP documentation.• Completed site change control initiator utilizing Trackwise computer tracking system training.• Met all commitment deliveries on time.

Validation Specialist I 01/06-11/07• Volunteered for short-term assignee at the Wyeth Grange Castle Site, Ireland.

1. Coordinated gap analysis activities between Sanford, NC and Grange Castle, Ireland sites.2. Created recommendations for gap closure between Sanford, NC and Grange Castle, Ireland sites.

• Led effort for Train 1 Building 110 autoclaves and 2500L Fermentor annual re-qualifications. • Led effort to present change control for implementation of Low Conductivity Final Rinse Alarm to Site

Change Control Committee for HAMO parts washers; completed validation activities deliverables for implementation. Final Report approved prior to commitment date.

• Led the effort for the IOQ of the Heat Exchanger 351978. Final Report approved in a cycle time of 29 days.

• Led the effort for the IOQ of five Hot Lips tube sealers. Final Report approved with an average cycle time of 45 days.

• Assisted with Operation Qualification (OQ) of over 25 fixed vessels for Building 110.• Mentored and trained contractor on use of Kaye Validator.• Completed dry-run testing and assisted with re-qualification of 2500L Fermentor SIP addendum.• Assisted with the OQ addendum for the Ultrafiltration Skid 120246 in Building 110.

Employment Wyeth continued Sanford, N.C. History Validation Specialist I continued 01/06-11/07

• Assisted engineering with troubleshooting and resolution for SIP issues associated with SIP of buffer prep and buffer hold vessels.

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KEVIN P. JACKSON 1257 Hill Hollow Way Apex, NC 27523kpjack1974@hotmail.com Home (919) 290-2720 Cell (843) 616-0883____

• Assisted with the Installation Operational Addendum of the 15L portable vessels 351991 and 351992. Final Report approved in an ``average cycle time of 37.5 days.

• Assisted with Technical Review for seven (7) Performance Qualifications for Facility Cleaning of Classified Rooms associated with the AC units in Train 1 Building 110.

• Assisted Cleaning Validation Dry running of buffer prep Performance Qualification taking samples and tachometer readings. Assisted with post-execution review of buffer prep PQ and Hold protocols.

Technical Services Technician I 10/03-01/06• Written, executed and completed validation studies and protocols in Building 101 and 110.• Responsible for sample collection and submission to the QC labs, document review, and data

collection for Process Validation studies and qualification activities.• Supported Vaccine Technology with the cell bank remediation efforts for HibTiter cell banks.

Assisted with cell banking process characterization studies (became skilled in aseptic techniques and culture propagation).

• Implemented hollow fiber filters for purification processes for Meningitec-C Vaccine.• Coordinated Kaye Validator training for contractors.• Have given support and/or executed the following evaluation studies:

1. Lyophilizer sucrose temperature mapping, pressure, and time profiles (2 evaluation cycles) 2. Process Trial Batch (PTB) Baseline Parameter Evaluation, and Process Parameter Value

Confirmation• Assisted in the development and performed the technical review for the Chemistry 6B and 9V

Process/Equipment/ Automation Evaluation Study Protocol. Study protocol was drafted and pre-approved 1Q05.

• Took the initiative and demonstrated abilities to successfully complete assigned validation activities supporting Chemistry area start-up.

• Transitioned to the Building 110 Train 1 Technical Services Equipment Validation Group to assist with and/or lead equipment OQ protocol development and execution(s).

Employment Kelly Services at Wyeth Sanford, N.C. History QA Documentation Specialist 07/03-10/03

• Responsible for the migration of all SOP’s, training materials and other documents onto GXPharma.• Authorization and Review of all documents migrated on to GXPharma. Assured all documentation

was accurately maintained.

United States Army Reserve Fort Jackson, S.C.Civil Affairs Sergeant 08/98-09/06• Analyze, process, and coordinate all documentation data for unit members to obtain security

clearances.• Mentor and supervise two subordinate soldiers.• Deployed in support of Operation Joint Forge Tuzla, Bosnia, Operation Noble Eagle Fort Bragg, N.C.

and Operation Enduring Freedom Bagram, Afghanistan.

Employment S.C. Probation Parole Florence, S.C.History Journeymen Agent 07/98-07/03

• Coordinated various supervisory activities to include receiving monthly reports, verifying residences and employment for at least 100 parolee/probations.

• Maintained detail data records of all parolee/probation progress, shortcomings and completing of court or board ordered sanctions. Conduction lawful arrest warrant services when needed.

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KEVIN P. JACKSON 1257 Hill Hollow Way Apex, NC 27523kpjack1974@hotmail.com Home (919) 290-2720 Cell (843) 616-0883____

• Liaison between probation/parole office, Florence county court system, solicitors’ office, detention center and public defenders office in scheduling revocation proceedings.

• Managed at least 100 probation/parole cases.• Consistently maintained clean, attractive working area and well-organized case files.

Skills Computer Skills: Hardware/Software:MS Word, Excel LIMS / LACES SAPGMPharma Windows 2000, XP OD SpectrometerData Logger Trackwise Kaye Validator 2000Calibration Manager (CALMAN) Met One Particle Counter

Professional Membership / CertificationISPE GE Kaye Validator 2000 BioProcess Technician

References Available upon request.

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