1. MAYRA I. CASIANO
310 Kathy Ellen Drive
Vallejo, CA 94591
Cell: (240) 401-7020
E-mail: mayracasi@aol.com
SUMMARY
• Extensive experience in medical devices (chemical reagents, patient care
components, hemostatic gauze) pharmaceutical/biotechnology industry
manufacturing, process/packaging, technical services, and validation, for existing
and new product launches.
• Installation, operation and performance protocols’ writing and execution for
process & packaging equipment, process utilities and facilities to support
regulatory agencies and companies requirements.
• Experienced in the validation programs for systems, facilities, equipment,
manufacturing processes and cleaning activities.
• Ensure timely execution, review and approval of validation protocols / reports
and SOPs (as needed).
• Led manufacturing operations, processing and packaging of solid, semi-solid and
liquid dosages, and packaging of medical devices, under regular and aseptic
operations. Directed solid dosages manufacturing shift activities of up to 15
employees.
o Coordination of manufacturing activities per production plan.
o Blending, granulation (wet (e.g. propranolol) and dry (e.g. diazepan)) and
compression of solid-dosages (generic).
o Blending of oral contraceptive granulation.
o Mixing of chemical reagents, tablets, vaginal creams.
• Drove implementation of technology transfer by coordination of the required
manufacturing activities. Manufacturing and validation SOP preparation and
required updating.
o Glatt dry blender (to increase capacity).
o Medical Devices: Hemostatic Gauze (Surgicel) – Technology transfer,
cutting, filling and packing. (Approved by FDA).
o Semi-solid: Renova: photo-damaged cream – Technology transfer, full
scale batches for FDA evaluation
• Provided hands on support as required / assisted in problem solving of Buffer
preparation area uniformity issues. Collected and analyze data to make data
driven recommendations/decisions.
o Visual inspection after ingredients addition for non-dissolved ingredients
o pH readings. (Sampling valve and top).
• Acting Validation/QA approver of oral suspension batches: final packages review,
discrepancies review and approval and final packages approval.
• Knowledge of GMPs, validation principles and guidelines, and compliance with
GMPs, OSHA, EPA and the direction of training programs on these issues.
• Change control program and corrective and preventive action and its
implementation in a solid dosage manufacturing area.
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2. MAYRA I. CASIANO
o Identification of discrepancy source and establishing a corrective action
via either procedures review/revision and equipment evaluation/repair.
SUMMARY (Continued)
o Ensure that the operators were re-trained; applicable documents (Master
Formula, procedures, forms) were revised as necessary.
• Evaluated Annual Product Review books data and recommended corrective
actions or approvals as applicable.
o Samples evaluation, to confirm that the batches under the stability
program met the product potency and acceptance criteria.
o Customer complaints records were maintained and any complaint was
addressed accordingly.
SKILLS
• Managed process discrepancy/deviation investigation and reports program for a
solid dosage manufacturing company.
• Broad range of expertise in medical devices, pharmaceutical and biotechnology
quality, commissioning and validation activities.
• Knowledge of GMPs, validation principles and guidelines for solid dosages & APIs.
• Detail-oriented with excellent review skills.
• Software skills: Microsoft tools namely Word, Excel, Visio and Power Point.
• Have good written and oral English skills.
• Have excellent written and oral Spanish skills.
• Experienced in establishing goals and objectives to complete assignments.
• Excellent interpersonal, analytical and communication skills.
• Knowledge of temperature monitoring equipment such as Kaye Validator 2000
and TempTales.
• Work as a team player and deliver corresponding assignment on timely basis.
Work independently and with the minimum of supervision.
• Flexible and willing to follow through to ensure that the job gets done.
ACCOMPLISHMENTS
• Accomplished proficiency in the development and execution of commissioning
and qualification protocols for biopharmaceutical unit operations (equipment,
processes and cleaning) and utility/facility support systems.
• Experienced in user requirements, commissioning and standard operating
procedures writing.
• Improved executed validation packages status tracking and final packages
completion by preparing quick glance punch lists.
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3. MAYRA I. CASIANO
• Interacted dynamically to coordinate equipment availability and personnel
support for minimal interruption of manufacturing activities and timely sampling
testing.
• Established good working relationships with clients/customers.
• Successful 100% execution of protocols without operator’s related errors.
Naderi Engineering, Inc. Danville, CA (Feb. 2012 – Dec. 2014)
Senior Validation Specialist – Validation services at Novartis, Emeryville and
Genentech, Vacaville.
• Prepared and executed protocols for a New Seed Lab Area Modification. The
assignment included a new Air Handling Unit Installation and Operational
protocol preparation and execution to evaluate its impact in the area by verifying
airflows and room differentials. Protocols generation for temperature control
units such as incubators, refrigerators and freezers.
• Prepared Risk Management Assessment (Hazard Analysis) for an air handling
unit documenting system risks, applicable remediation/risk reduction and critical
controls.
• Maintain Training requirements up to date to ensure job responsibilities could be
performed as scheduled.
• Assisted the Engineering and Documentation Control with as-built reconciliation
of Process and Instrumentation Drawings (P&IDs) for facilities, utilities and
process equipment.
• Performed a gap assessment of all Temperature Control Units (TCUs) which were
used in a Diagnostics Manufacturing area. The assessment was performed by an
evaluation of manufacturing documents (such as Batch Production Documents
(BPDs), Standard Operating Procedures (SOPs)) and Critical Process Parameters
(CPPs) against qualified TCUs temperature ranges.
Total Validation Services, San Ramon, California (2001 – 2011)
Senior Validation Specialist – Validation services at various assignments such as
BioNovo (Hayward), Alza (Vacaville), Genentech (Vacaville), BioMarin (Novato), Amgen
(Formerly Abgenix (Fremont), Bayer (Berkeley), Cell Genesys (Hayward), Aradigm
(Hayward), Durect (Cupertino) and Nektar (Formerly Inhale Therapeutics (San Carlos).
• Prepared Commissioning protocols for process equipment such as: Blast
Freezers, Biosafety Cabinets, Filter Integrity Testers, Flow Hoods, Freezers,
Incubators, Water Bath Circulators and Sterile Tube Fusers.
• Prepared and executed Installation and Operational Qualification protocols for
process equipment such as: bioreactors, tanks, decanter, centrifuge, RO Skid,
UFDF Skid, CIP Skid, Blast Freezers, Biosafety Cabinets, Filter Integrity Testers,
Unidirectional Flow Hoods, Freezers, Incubators, Water Bath Circulators and
Sterile Tube Fusers.
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4. MAYRA I. CASIANO
• Prepared and executed Installation, Operational and Performance Qualification
protocols for utility systems such as: RO/DI, Purified Water, Clean Dry Air, Clean
Steam, Nitrogen, and Oxygen.
• Prepared and executed Installation, Operational and Performance Qualification
protocols of Fluid Bed Granulator (Glatt), lubricators for the granulation phase of
Ditropan.
Total Validation Services, San Ramon, California (2001 – 2011) Senior
Validation Specialist
• Prepared and executed temperature mapping of control temperature
environments such as refrigerators, incubators, freezers and a blast freezer
using Validator 2000 and TempTales.
• Prepared and executed Autoclave and Dry Heat Oven Performance Qualification
for various loads including Biological Challenges (B. Stearothermophilus) and
Endotoxin challenges, respectively.
• Prepared and executed protocols for a Fill Finish Area Modification: Media Fills
(Filling and Stoppering Machines Performance Qualifications). It also included, a
new Air Handling Unit Installation and Operational protocol preparation and
execution to evaluate its impact in the area by verifying airflows and room
differentials, air direction (smoke studies).
• Prepared Facility Installation Qualification protocol for clinical manufacturing
facility.
• Prepared and executed steam-in-place (SIP) and clean-in-place (CIP) protocols
for transfer lines.
• Prepared and executed mixing studies for media and buffer tanks.
• Prepared executed protocols final reports and final packages.
• Reviewed executed/completed validation packages for accurate and complete
data results reporting, compliance with the approved protocol acceptance criteria
and applicable procedures; prior submission to the clients.
• Communicated and coordinated with manufacturing the equipment and
resources needs in advance to ensure a minimal interruption of the
manufacturing activities and a smooth equipment set-up and personnel support
for execution.
• Reviewed and provided support in the preparation of Validation Master Plans and
Installation and Operational Qualification protocols templates.
Life Sciences International (1997 – 2001)
Senior Validation Specialist – Validation services at various assignments such as
Aventis Behring (Illinois), Alpha Therapeutics (California), North American Vaccine
(Maryland) and McNeil Consumer Healthcare (Texas).
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5. MAYRA I. CASIANO
• Prepared and executed Facility Installation Qualification protocols for
manufacturing areas of injectable plasma products.
• Prepared Installation Qualification protocol for a vials’ labeler.
• Executed Re-qualification protocols for fermenters.
• Prepared and executed chemical depyrogenation studies and cleaning validation
activities for Clean-in- Place of Ultrafiltration Systems, processing vessels,
fermenters and glassware washers.
Life Sciences International (1997 – 2001) (Continued)
• Development of IQ for facility modification and environmental monitoring of
manufacturing room.
• Reviewed data and summary reports for autoclaves and fermenters
requalifications.
• Prepared process equipment Installation/Operational Qualification protocols for
fluid bed granulator, air handlers, kettles, sanitary pumps, volumetric feeders,
agitators/aerators and glassware washer and dryer. (As part of a granulation
room up-grade).
Zenith Laboratories Caribe, Inc., Cidra, PR (1994 – 1997)
Manufacturing Supervisor / Senior Validation Specialist
• Directed solid dosages manufacturing shift activities of up to 15 employees.
• Developed and executed solid dosages process validation, drying studies and
Installation/ Operational/Performance Qualification protocols for equipment
which include blenders, granulators, compressing and encapsulating machines,
mills, metal detectors, capsule polishers and bar code system.
• Managed change control program and oversaw corrective action implementation
in a solid dosage manufacturing area.
• Reviewed data and summary reports for oral suspensions mixing studies,
validation approver of oral suspensions and solid dosages batches.
• Managed process discrepancy/deviation investigation and reports program for a
solid dosage manufacturing company.
• Interpreted and compared stability samples testing results versus final product
specifications.
• Evaluated Annual Product Review books data and recommended corrective
actions or approvals as applicable.
ADDITIONAL EXPERIENCE
Ortho Pharmaceuticals, Inc. - Manati, PR - Manufacturing Supervisor /
Technical Support
• Responsible for semi-solid product manufacturing start-up.
• Technical support, investigations and audits/reports of manufacturing area.
Baxter - Pharmaseal – Toa Alta, PR – Packaging Supervisor
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6. MAYRA I. CASIANO
• Directed the packaging of medical devices (patient kits) and molding department
intravenous bags’ valves) activities.
Beckman Instruments Caribe, Inc. (Beckman Coulter) – Naguabo, PR -
Formulations Supervisor
• Directed the processing of chemical reagents (liquid form) products for
blood/plasma analysis. Manufacturing support of new product transfer.
Bristol Alpha Corporation - Barceloneta, PR - Finished Products Laboratory
Supervisor
• Directed the finished product testing (solid dosages, vials and oral suspensions).
EDUCATION:
Bachelor of Science in Chemistry, University of Puerto Rico, Mayagüez Campus
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7. MAYRA I. CASIANO
• Directed the packaging of medical devices (patient kits) and molding department
intravenous bags’ valves) activities.
Beckman Instruments Caribe, Inc. (Beckman Coulter) – Naguabo, PR -
Formulations Supervisor
• Directed the processing of chemical reagents (liquid form) products for
blood/plasma analysis. Manufacturing support of new product transfer.
Bristol Alpha Corporation - Barceloneta, PR - Finished Products Laboratory
Supervisor
• Directed the finished product testing (solid dosages, vials and oral suspensions).
EDUCATION:
Bachelor of Science in Chemistry, University of Puerto Rico, Mayagüez Campus
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