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Process Technician Manufacturing Operator

Location:
Raleigh, NC
Posted:
July 09, 2021

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Resume:

Lisa Eliassen

**** ****** ******* ****** *******, NC

919-***-****

adnm7q@r.postjobfree.com

QUALIFICATION SUMMARY

A top-performing pharmaceutical and manufacturing professional with proven technical process knowledge, and a strong leadership, team-work attitude. Commended for completing projects with a high level of quality and efficiency. Strong knowledge in the setup, disassembly, cleaning, and reassembly of equipment used in the pharmaceutical manufacturing process. Proven leadership skills with mentoring and training operators and assisting in Just Do It programs to improve quality, efficiency, and safety.

Areas of Expertise

In-Process Sampling & Testing

Hazard Identification SOP, GMP, LOTO & PAPR

Safety Training

Knowledge of Microsoft Office

Operator Training

PROFESSIONAL EXPERIENCE

Tergus Pharma, Durham, NC April 2021-present

Process Technician II

Operation of equipment and instruments within the clinical trial manufacturing area, including dispensing, filling, compounding, and packaging

Troubleshoot and perform necessary equipment repairs

Execute equipment qualification and validation protocols

Routinely draft and revise standard operating procedures and master batch records

Recognize and initiate process deviations

Support continuous improvement initiatives

Effectively communicate, both written and verbal

Ensured a safe working environment for all staff

Novo Nordisk, Clayton, NC February 2021- Apr 2021

Formulation Technician

Works in aseptic environment within the formulation area

Weighing of materials utilizing Pas-X and MES systems

Performs formulation of insulin and media

Monitor and control automated equipment through HMI

Review and document data in batch production record concurrently and correctly

Perform proper PH testing at conclusion of batch, utilizing batch production record and SOPs

Cleaning of parts, equipment and room by utilizing Aseptic cleaning methods

Aseptic gown certified

Catalent Pharma Solutions, Morrisville, NC

Process Technician

August 2018-Feb 2021

Works in a sterile filling environment on up-stream and down-stream processes

Operates semi and automated equipment to meet production standards

Prepares equipment and materials for production

Perform data entries and batch record reviews

Gown room certified

Amazon Flex, Raleigh, NC November 2015- April 2018 Delivery Driver

Responsibilities included scanning and delivery of packages to customers

Skills utilized: excellent customer service, attention to detail, organizational skills, and the ability to multitask

Biogen Research Triangle Park, NC June 2012-April 2015 Manufacturing Associate II

Responsible for the setup, operation, cleaning, disassembly and reassembly of various equipment used in the pharmaceutical manufacturing process to include dispensing, granulation, milling, drying, blending and coating.

Reviewed and revised standard operational procedures and batch documentation.

Performed data entry and processed work orders.

Performed in-process sampling and testing.

Mentored and trained operators which required excellent leadership and interpersonal skills.

Active member of the safety team to improve the safety standards of the company and trained to be a first responder on the Medical Emergency Response Team.

Performed 5S and safety audits on a regular basis.

Burts Bees, Morrisville, NC December 2008 – October 2010

Process Technician

Setup and operated equipment used during the compounding process, including pumps, mills, hoses, fittings, homogenizers and mixers/tanks.

Entered batch information into the computer and checked inventory.

Performed in-process sampling and testing of products to ensure they meet the Standard Operating Procedures (SOP), Good Manufacturing Practices (GMP), and safety regulations.

Performed routine safety audits.

Mentored and assisted fellow operators when necessary.

GlaxoSmithKline, Zebulon, NC July1999 – April 2008 Manufacturing Operator III

Performed various duties to include dispensing, granulation, drying/milling, blending and coating equipment with Vector and O’Hara Coaters.

Performed the operation and cleaning of all equipment according to the Standard Operating Procedures (SOP), and Good Manufacturing Practices (GMP).

Operated manufacturing equipment to meet all team production goals.

Performed in-process testing.

Reviewed and revised SOPs.

Participated in problem solving and brainstorming to resolve mechanical, processes, and safety issues.

Used computers and network systems to access SOPs, production schedules, and material ordering and control specifications.

Monitored the production operations to ensure product quality and integrity.

Supported operational excellence initiatives and helped to promote Just Do It programs for continuous improvements in quality, efficiency, and safety.

Mentored and trained operators.

Education & Training

Bachelor of Art, Health Management, DeVry University Addison, IL (in progress)

Certification

Career Readiness Certificate

Microsoft Office Suites (Word, Outlook, Excel)

Industrial Pharmaceutical Technology

SAP

Powered Air Purifying Respirator (PAPR)

Lock Out Tag Out (LOTO)

People-based Safety Training



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