History Validation Specialist Resume

OBJECTIVE

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

TECHNICAL SKILLS

PROFESSIONAL EXPERIENCE

Confidential

History Validation Specialist

Responsibilities:

Lead temperature mapping of cold temperature units.
Assist automation validation with qualification of Delta V defined media code changes.
Assist with HEPA filter recertification.
Led steam sterilization for fermentation vessels.
Led investigation for cGMP process equipment 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

Confidential

Responsibilities:

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

Confidential

Responsibilities:

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.
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.