John File
Brownsburg,IN
Summary
Highly motivated and experienced Formulation, Prep, and Filling operator with fifteen years of experience in the pharmaceutical industry. Proficient at training new team members, recommending process improvements, and communicating to all levels of the management. Adept at learning new processes and software. I welcome challenges and am always looking for ways to learn and improve.
Experienced with leading teams to achieve project goals through effective management and strategic planning. Utilizes strong organizational and communication skills to foster collaboration and drive performance. Track record of successfully overseeing project execution and adapting to dynamic work environments.
Overview
22
22
years of professional experience
Work History
Team Lead Formulation
Incog Biopharma
03.2022 - Current
- Lead Team in daily operations and formulations
- Daily reviews of MBRs, Forms, and Logbooks
- Write SOPs for formulation and filling areas/equipment
- Create logbooks for equipment use/room use/sanitizations
- Perform dispensing/formulation of media and drug products
- Perform in-process testing
- Move/Consume materials in SAP/ERP
- Conduct filter integrity testing using IT5s
- Train new operators
- Perform MBR reviews for MSAT to ensure accuracy and help streamline actual production
- Perform filling operations when needed
- Operation of Autoclave/Parts washer
- Member of Emergency Response Team, CPR certified
- Regularly conduct safety walk throughs of all areas
- Assisted with EMPQ sampling
- Regularly work in Grade C/D areas
- Assist with completing CAPAs
- Forklift certified
- Work closely with support groups
- Trained new team members by relaying information on company procedures and safety requirements.
- Promoted a positive work environment by fostering teamwork, open communication, and employee recognition initiatives.
- Served as a role model for the team by demonstrating commitment to excellence, professionalism, and adherence to company values at all times.
- Coached team members in techniques necessary to complete job tasks.
- Enhanced overall team performance by providing regular coaching, feedback, and skill development opportunities.
- Influenced positive change within the organization through strategic thinking, innovation, problem-solving abilities, and consistent leadership style.
Production Technician 3
Exelead Biopharma
09.2021 - 03.2022
- Lead team of 2-7 people while performing Complex Formulations
- Work closely with support groups
- Review tickets for accuracy
- Check in materials
- Dispense bulk materials to obtain required quantities for formulation
- Help train new individuals
- Prepare equipment for autoclaving
- Regularly worked in Grade C/D areas
- Trained new team members on equipment operation, safety protocols, and company policies
- Performed regular calibration checks on instruments ensuring precision measurements throughout production processes
B4 Floor Lead Formulation and Prep
Eli Lilly
02.2016 - 07.2021
- Expertise in Form/Prep processes
- Help perform Safety Audits, Walk-Throughs, and BSafes
- Experience using SAP, Palleti, and Darwin
- Daily reviews of Paper Tickets and all Form/Prep logs
- Accountable for 7-10 operator’s day-to-day activities on Production Floor
- Ensure employees’ daily operations are done per cGMPs and/or SOPs
- Perform B5 responsibilities when B5 unavailable
- Help create and implement improvements to processes
- Identify and resolve day-to-day operational problems
- Serve as consultant when problems with little to no precedent arise
- Developed employee schedules, balancing individual preferences while meeting operational business needs effectively.
- Resolved conflicts between employees professionally, fostering positive working environment that encouraged collaboration rather than competition.
- Collaborated with other departments to drive successful completion of assigned tasks.
B2 Operator for Formulation and Prep
B2 Operator for Formulation and Prep
08.2014 - 02.2016
- Train fellow prep operators
- Work with multiple departments to achieve common goals
- Aseptic gown qualified
- Perform SIP/CIP
- Perform loading and unloading of autoclaves
- Conduct filter integrity testing using IT4s and IT5s
- Perform drug product formulations
- Perform aseptic personnel monitoring
- Work in equipment prep
- Lead prep while B4 was performing formulation
- Communicate with aseptic operator and supervisors to coordinate turnaround of filling equipment
- Regularly worked in Grade C/D areas
- Provided on-the-job training to newly hired workers and team members.
Capacity Planner/Scheduling Assistant Planner/Blu-Ray Disc Molder
Sony DADC
Terre Haute , IN
05.2008 - 08.2014
- Train/assist operators as needed
- Assist other departments when needed
- Assign orders to machines for Molders to run minimizing downtime
- Placed and rerouted orders to other companies to ensure completion time was met
- Assign orders to meet specified start times and schedule for shortages
- Create and cancel orders
- Run quality reports to find orders that should be completed but are not
- Assign reasons as to why orders have shipped late
- Motivated self-starter with minimal supervision
- Set-up and operation of multiple molding machines in a clean room environment
- Periodically do Quality Assurance inspections to ensure no visual or functional defects
- Work with multiple departments to ensure machines meet production standards and quantities
- Maintain cleanliness of machines and surrounding areas
Quality Assurance Service Operator
Pfizer
Terre Haute, Indiana
01.2007 - 05.2008
- Provide majority of quality assurance downstream of formulated product in aseptic and clean room environments
- Take and test samples of aseptic equipment and personnel
- Effectively perform weekly assessments of clean room areas to ensure cleanliness, proper rotation of consumable items (FIFO), and ensuring cGMPs are followed.
- Assist production with packaging of finished products
- Perform regular inspections of processed and packaged products to look for minor, major, and critical defects
- Participate in C-crew cGMP team looking for items within production building not up to company standards or cGMP standards and reporting items to QAS Manager
- Thoroughly record all data using Good Documentation Practices, and initiate Exception Reports when unacceptable results are found
- Effectively check in components and products ensuring all components are for correct batch
- Take samples of all components from each lot number used and place within QAS batch record
- Consistently work with Shift leaders within QAS and other departments to resolve unacceptable production results
- Perform line clearances of manufacturing lines prior to and after batches
- Thoroughly review paperwork to ensure GDP has been followed
- Assist with batch record creation
Fill Room Operator 4
Baxter Pharmaceuticals
Bloomington, IN
06.2003 - 01.2007
- Lead operator in multiple rooms
- Successfully took over in team leader’s absence
- Independently took prompt action to proactively accomplish objectives and achieve goals beyond what is required
- Effectively communicated with various shifts, departments, and supervisors
- Reviewed project plans andbatch records prior to and following operations, increasing efficiency while ensuring that no deviations, investigations, or rejection of batches will result due to documentation errors
- Effectively followed established procedures to ensure accurate documentation of information
- Periodically worked upstream formulating product for aseptic fills
- Trained and observed new operators to ensure proper aseptic techniques and teach Standard Operating Procedures including observation of personal hand fills, setup and operation of new machines, trouble shooting of machinery, and proper filtration for all products
- Lead media fills and validation fills ensuring all fill objectives are covered
- Knowledge and capability to independently perform and lead aseptic filling operations in a Class 10,000/100 area regularly working downstream of formulated product
- Specialized in a minimum of two aseptic filling suites while being a support operator for additional areas while using mechanical aptitude to determine if the components are functioning properly
- Perform Environmental Monitoring agar plates including fingertip touch plates, contact plates, fallout plates and slit-to-agar plates
- Effectively setup, operate, and troubleshoot aseptic filling equipment while ensuring that all setups are completed in a timely and aseptic manner
- Effectively and efficiently performed routine cleanup, organization, and sanitizations of various fill rooms according to current Good Manufacturing Practices
- Assisted QA in situations that are irregular for the normal batch procedures
- Effectively provided comments for irregular occurrences during normal batch procedures
- Understand cGMP procedures to correctly perform job requirements and to prevent changes that could negatively impact batches and/or differ from specific client requests
- Consistently examined (SOPs, equipment, methods, etc.) to prevent errors and/or recognize unexpected results
- Thoroughly performed routine verification of equipment when unloading autoclaves, unloading dispatch oven and setting up aseptic filling machines
- Effectively coordinated and prioritized own time and daily activities to ensure that projects were completed efficiently
- Effectively wrote exception reports, comment on batch records, assist Tech Services in batch record creation
- Practiced proper technique to avoid microbiological contamination
- Loaded and unloaded lyophilizer, performing clearances and sampling
- Operated various types of machinery, demonstrating versatility and adaptability in diverse work environments.
Education
High School Diploma -
White River Valley High School
Switz City, IN05.1998
Skills
- Skilled in Microsoft Office applications for productivity tasks
- Experience with SAP systems
- Palletti
- Darwin
- Attention to detail
- Conflict resolution
- Coaching and mentoring
- Workplace safety
- Customer focus
- Process improvement
Timeline
Team Lead Formulation
Incog Biopharma
03.2022 - Current
Production Technician 3
Exelead Biopharma
09.2021 - 03.2022
B4 Floor Lead Formulation and Prep
Eli Lilly
02.2016 - 07.2021
B2 Operator for Formulation and Prep
B2 Operator for Formulation and Prep
08.2014 - 02.2016
Capacity Planner/Scheduling Assistant Planner/Blu-Ray Disc Molder
Sony DADC
05.2008 - 08.2014
Quality Assurance Service Operator
Pfizer
01.2007 - 05.2008
Fill Room Operator 4
Baxter Pharmaceuticals
06.2003 - 01.2007
High School Diploma -
White River Valley High School
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