Team Members Associate Iii

ORLANDO LIVINGSTON

*** ****** **** **, *************, WV 25443

787-***-**** *******.**********@*****.***

A highly skilled professional with proven trac-record working in the manufacturing/pharmaceutical industry seeks a job to contribute experience and abilities to promote company’s objectives and growth.

EXPERIENCE

January 28, 2019 to September 28, 2024

MFG ASSOCIATE III, LONZA, WALKERSVILLE MD

Responsible for performing production functions in the Class 100 cleanroom (core) and Finishing area according to company and Departmental SOP’s.

Set up and Operate production equipment.

Maintain records to comply with Good Manufacturing Practices and Standard Operation Procedures.

Complete Fill-Finishing schedule.

Primary trainer for entry & mid-level staff members.

Knowledgeable and compliant with all pertinent safety policies, rules and regulations.

Use aseptic techniques.

Ensure that all team members comply with safety rules and regulations.

Provides appropriate coaching and performance feedback to all direct reports and assures that all team members are being developed.

January 2016 to June 2018

Blending Operator, Jubilant Cadista Pharmaceuticals, Salisbury MD

Perform screening, granulation, drying, milling, compaction and blending processes.

Check raw material expiration dates and weights, as per Batch Record requirements.

Use the correct Personal Protective Equipment and follow safety procedures.

Set up equipment and calibrate scales.

Assure product quality by setting up, operating or tending machines to mix or blend materials.

Observe machine gauges and equipment operation to detect defects or deviations from SOPs, and make adjustments as necessary.

Record operational data on Batch Record or specified Forms.

Follow company policies, cGMP and Standard Operation Procedures.

Load and unload blenders in containers following the mixing process, weighting and labeling the final product. Perform batch review, calculations and reconciliation.

Perform tank, room, and equipment cleaning after the batch is complete.

Perform sanitization.

Apr 2011-Agust 2014

MANUFACTURING ASSOCIATE III, AMGEN, JUNCOS, PR

Successfully worked with controlled substances in Biotechnology setting. The operating steps included set-up, filling, sealing and packaging processes.

Inspected vials of protein-based injectable drugs.

SAP and Electronic batch record knowledge.

Operated equipment and made needed adjustments to reduce product loss, maximize output and ensure product quality.

Ensured all components and equipment were ready for manufacturing and packaging; cleaning and operating equipment, such as vial washers, stopper treatment, capper, sealing and packaging machines. Transferred materials between work centers to meet the formulation and filtration daily schedules.

Monitored operating parameters and physical attributes of products during manufacturing and packaging process.

Microbial air sampling in aseptic room.

Performed sanitation procedures in the aseptic room, equipment and general area, and maintain sterilized equipment and clothing as per SOP.

Observed all safety measures, GMPs, SOPs and batch record requirements, met security standards, protocols and strict adherence to safeguard quality control in all the production cycles.

Effectively addressed production problems such as equipment malfunction, changes in raw materials or products and process disruption.

Documented and maintain records to validate quality standards, attended meetings to discuss audit reports.

Efficiently interacted with process specialists, equipment specialists, quality specialists, planners, and procurement personnel.

Trained and mentor new personnel.

Handled process deviations and joined troubleshooting meetings to coordinate input and ensure processing problems and requirements were explained and corrections expedited.

Aug 2006 – Jan 2011

Manufacturing operator I, Wyeth/Pfizer Pharmaceutical, Carolina PR

Responsible for equipment preparation for manufacturing.

Perform sterilization cycles, loading and unloading lyophilization equipment, cleaning and operating equipment such as autoclaves, ovens, vial washers, and packing machines.

Set up, Filling, Sealing and packaging process execution.

Perform sanitization procedures in the aseptic room,equipment and general areas as per SOPs.

Production fill dose checking.

Know and follow safety policies and cGMP involving self and other team members, Lock out /Tag out, (PPE) utilization, gowning, housekeeping, good documentation practice and cross contamination prevention.

Monitor operating parameters and physical attributes of products/process during each manufacturing steps.

Assists routine preventive maintenance.

Formulation Operator, McNeil Consumer, Johnson & Johnson Las Piedras P.R. (Feb 2005-June 2005)

Effectively execute the Formulation process of gel and handle in-process of bulk materials for various Tylenol products.

Performed bulk preparation for the process line and loading tanks, monitored cooking, unloading of product and coating preparation. Inspected the production line to identify the expiration date of materials and suppliers’ products.

Perform CIP to tanks.

Education

Turabo University, Gurabo P.R. ; BA Degree in Natural Science-Biology; 2002.

PR Technological Institute, San Juan P.R. ; AS Degre in Mechanical Engineering Technology; 1998.

Skills & Abilities

Over 10 years’ experience in Biopharmaceutical Manufacturing.

Understanding of cGMP, SOPs, MPRs and SPRS.

Clean room experience with aseptic techniques to comply with regulatory requirements.

Follows and ensure a safe work environment in accordance with the corporation standards.

Assisted in the execution of validation protocols.

Experience in Microbiology and Environment monitoring.

Mechanical aptitude,attention to details, problem solving aptitudes.

Good team player and excellent interpersonal relations.

Computer skills and Bilingual (English and Spanish )

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