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senior fill finish lead resume example with 14+ years of experience

Jessica Claire
  • , , 609 Johnson Ave., 49204, Tulsa, OK 100 Montgomery St. 10th Floor
  • H: (555) 432-1000
  • C:
  • resumesample@example.com
  • Date of Birth:
  • India:
  • :
  • single:
  • :
Summary

I'm a knowledgeable, experienced Bio-process technician. With extensive knowledge and experience working with PFS and vial equipment for filling those vessels. I'm enthusiastic about working with people and teams of all backgrounds to transform pharmaceutical companies into more productive processes. Highly organized, energetic and versatile leader committed to continuous improvements. Proven history of motivating staff to work together to achieve targets and goals. Creates success by learning new process, maintaining professional environments and taking the lead in development of procedures for the process. Areas of expertise include leadership qualities, aseptic filling operations, Vial Washer, Depyrogentation Tunnels, Filler/Isolators, troubleshooting, preventive maintenance, machine operation and mechanically inclined.

I feel with my experience and training would qualify me to be an asset to a company that aims for Excellence, Integrity and Relationships.

Skills
  • Positive Attitude
  • Aseptic Techniques/Aseptic gowning
  • Bausch & Stroebel Fillers (12 needles), Depyrogenation Tunnels and Vial Washers
  • LSI lyphilization freeze dry systems
  • Terminal Sterilizer Autoclave
  • Pharmaceutical Packaging Systems
  • Rota PFS (Pre-filled syringes) machines
  • Mes, Delta-V, LIMS, SAP and Blue Mountain
  • Environmental Monitoring
  • CIP, SIP, VHP and CZS (Cool zone sterilization)
  • Validation IQ, OQ and PQ
  • Mechanically Inclined
  • Excellent with tools / power tools
Experience
Team Lead , 07/2021 - Current
The Shyft Group, Inc. Novi, MI,
  • Leads shift when supervisor is unavailable, actively leads shift exchanges, works independently with minimal direction, coordinates activities and daily schedules with cross-functional areas.
  • Executes Aseptic manufacturing filling process steps within "A" space and manufacturing support activities, monitoring the process against the batch record SLR and control systems.
  • Coordinates and leads process steps as required, serving as SME.
  • Documents, records and reviews cGMP data and information for processing steps or equipment activities, following standard SOP's.
  • Develops and revises documents as needed, key documentation includes cGMP, batch records, SLR's and equipment logbooks.
  • Participates in training activities, provides training to other associates and shares knowledge with others.
Senior Fill/Finish Lead , 09/2016 - 07/2021
Kelsey Seybold Clinic College Station, TX,
  • Setup, changeover, operate, troubleshoot Groninger Isolator/filler, Depyrogenation tunnel and Vial Washer.
  • Assisted contractors with installing Groninger equipment during initial start-up phase
  • Participated in Validation of all Groninger and Snowbell equipment, ie: IQ, OQ and PQ
  • Executed aseptic filling process techniques within aseptic environment.
  • Formulation, filtration and prepare instruments for sterilization procedures.
  • VHP, SIP, CIP and Cool Zone Sterilization cycles.
  • Worked on eliminating issues on all machinery
  • Assists and covers for supervisor with shift activities, team management and motivation of team members.
  • Assists with CAPA's, batch record review, investigations, Scale Ups, Media fills, Exhibit batches and participated in mock and successful FDA audits.
  • Integrated process improvements to increase overall workflow.
Maintenance Technician, 03/2012 - 05/2016
Global Aviation Services Ontario, CA,
  • Setup, changeover, operate and troubleshoot Bausch and Stroebel Isolator/filler, Depyrogenation tunnel and Vial Washer.
  • Aseptic filling operator in aseptic process environment, trained in visual vial inspection.
  • Responsible for repairing Tare and Gross servo robots for Filler when clutch had disengaged.
  • Installed RTD's for 12 needles of Filler to regulate temperature of product as it flowed through needles, which would eliminate downtime.
  • Assists Validation with protocols, IQ, PQ and OQ.
  • Coordinated with Bausch and Stroebel vendors to prepare for training, large system installations and complex repairs.
  • Per EBR ran CIP, SIP, Depyrogentation Tunnel Cool Zone Sterilization via Delta-V and MES systems.
  • Performed PM's to ensure proper machine operation for production.
Supervisor, 04/2009 - 03/2012
Henkel Madison Heights, MI,
  • Established and enforced clear goals to keep employees working collaboratively.
  • Maintained operating schedules to provide effective coverage for key areas and achieve objectives.
  • Created training manual for all employees to use as reference guide for their respective areas.
  • Interviewed applicants, recommended individuals for hiring and evaluated staff performance.
  • Reduced process gaps, effectively managing and training 22-30 employees on best practices to ensure optimal productivity.
  • Conducted employee evaluations and reviews.
Chemical Operator, 06/2006 - 02/2009
Degussa City, STATE,
  • Operated fork trucks safely and reported process upsets, chemical releases and security events to appropriate departments.
  • Observed gauges, recording instruments and flowmeters to maintain specified conditions.
  • Tested product samples for specific gravity, chemical characteristics, pH levels, concentrations and viscosities, mixed batches for processes.
Education and Training
: Biology, Expected in
-
Alamance Community College - Graham, NC
GPA:
Status -
High School Diploma: , Expected in 06/1995
-
Alfred E. Smith High School - Bronx, NY,
GPA:
Status -
Certifications
  • Supervisor Certification from CAI in Raleigh, NC
  • CGMP and GDP certifications
  • Yellow Belt
  • Environmental Monitoring
  • Lock/Out Tag/Out
  • Arc Flash
  • Aseptic Gowning certification
,

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Resume Overview

School Attended

  • Alamance Community College
  • Alfred E. Smith High School

Job Titles Held:

  • Team Lead
  • Senior Fill/Finish Lead
  • Maintenance Technician
  • Supervisor
  • Chemical Operator

Degrees

  • Some College (No Degree)
  • High School Diploma

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