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Operator Manufacturing

Location:
Indianapolis, Indiana, United States
Posted:
March 13, 2018

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Craig E. Pinner

Career Summary

Maufacturing Operator with 20 years experience in the Pharmaceutical/Biotech industry. Strong understanding of GMP regulatory requirements as they relate to laboratory practices and manufacturing processes. Strong knowledge to work through production issues including basic troubleshooting skills, and use of tools. Excellent interpersonal, verbal and written communication skills. Quick learner, adaptable to fast-paced & changing environments. Thrive on using teamwork & promoting positive working relationships. Recognized for professionalism, positivity, commitment, & proven ability to maintain excitement and enthusiasm.

EXPERIENCE

Eli Lilly (Kelly Temporary Service) – Indianapolis, IN 07/2016 to 01/2018

Operator I

Set up, use, and operate the automated and semi-automated inspection machines in controlled facilities.

Follow the Parenteral Plant safety policies and procedures to contribute to a safe work environment.

Setup and operations in non-aseptic manufacturing processes

Operate PMX, Flow-stream or other electronic batch documentation system.

Adhere to standard operating procedures (SOP).

Certified in Good Manufacturing Practices (GMP); follow safety policies and procedures.

Document and process steps on the batch documentation (paper and electronic).

Participate in department meetings, team building, and training activities.

Provide input for department SOPs and training

Amgen, Inc. – Thousand Oaks, CA 06/1997 to 06/2016 Manufacturing Technician III

Achieved promotional advancement from earlier position as Inspections Operator III, Cell Culture Operator III, Purification Operator II, Formulation Operator II, Fill Group Operator II, Component Prep Operator, and Clean Technician Operator II

Perform solution and equipment preparation, raw material and single use parts dispensing for manufacturing processes in mammalian cell culture and purification processes.

Assembling and disassembling of equipment before and after use ensuring compliance with cGMP and safety requirements are met.

Participation in resolving problems during operations with partner groups QA and Process Development.

Perform hands-on execution of the plant operations and assist Manufacturing Associates trouble-shooting.

Prepare Stage components for autoclaving and washing.

Test integrity for sterilizing filters

Prepare environmental monitoring of classified manufacturing cleanroom.

Perform production activities involving buffers batching, formulation and filtrations.

Draft and revise documents for production batch records.

Inspected liquids filled vials, liquid filled syringes and lyophilized vials.

Assisted making buffer dilutions and aseptic removals

Prepare capping room operated the west capper and tray loader.

Prepare component cleaning, prepping and autoclaving equipment for the fill groups.

Prepare sanitization of corridors, processing areas equipment, wall, floor and ceilings.

United States Navy – Point Mugu, CA 11/1988 to 10/1995

Aviation Boatswain’s Mate

Operate, maintain and perform organizational maintenance on catapults, arresting gear, barricades and associated flight deck launching and recovery equipment.

Operate and service aircraft ground-handling equipment and machinery.

Operate and service aircraft crash, firefighting and rescue equipment.

Handle aircraft afloat and ashore; operate, maintain, and repair aviation fueling, defueling, lubricating oil, and inert gas systems; perform crash rescue, crash removal, and damage control.

EDUCATION

Pike High School - Indianapolis, IN

Graduated

MILITARY

United States Navy – Point Mugu, CA 11/1988 to 08/1995

Honorable Discharged



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