Martina Duffy
Clane
Summary
Manufacturing Process Technician with over 25 years of experience in high-pressure environments. Expertise in adhering to strict Standard Operating Procedures and Good Manufacturing Practices. Proven ability to maintain high levels of organization and attention to detail while meeting production goals. Strong team player with a positive attitude and commitment to excellence. Proficient in ALCOA.
Overview
13
13
years of professional experience
Work History
Manufacturing Process Technician
Amgen
Dublin
12.2023 - Current
- Certified in Grade C garb, ensuring adherence to cleanroom standards.
- Trained in operating ride-on pallet trucks for efficient material handling.
- Expert in the manual inspection of freeze-dried vials, liquid-filled vials, and syringes, guaranteeing product quality.
- Skilled in operating the Seidenader V90 for high-precision automated visual inspections.
- Competent in using Wilcomat computer systems to optimize lyophilization, capping, and inspection processes.
- Executed PAS-X transactions for batch record reviews, ensuring accurate completion and closure.
- Committed to safety excellence, actively submitting SEE cards to foster a secure workplace.
- Utilized LIMS for chain of custody transfers of samples to the sample room.
PQS Operator
BD Medical
Dublin
01.2020 - 12.2023
- Operated the pen needle production line within a high-volume manufacturing environment.
- Conducted regular performance assessments to maintain optimal machine operation.
- Executed seamless lot changes, ensuring no contamination between batches.
- Performed rigorous camera inspections post-lot change to guarantee production line efficiency. Performed maintenance work on the line, and regulated it to ensure that it runs flawlessly throughout the day.
- Maintained and adjusted machinery to achieve flawless operation throughout daily operations.
Bioprocess Associate
Bristol-Myers Squibb
01.2019 - 01.2020
- Downstream Bioprocess Associate operating in a Grade C cleanroom to the highest cGMP standards.
- Successfully completed comprehensive training modules, including classroom, online, and on-the-job training, within designated timelines.
- Proficiently executed Delta V recipe setups and managed MES workflows in strict adherence to SOPs and PBRs.
- Performed SAP entries for the consumption tracking of raw materials and consumables.
- Conducted in-process quality control tests, including pH, conductivity, and osmolality measurements for buffer preparations.
- Performed pH adjustments through titration using HCl and NaOH for buffer make-ups.
- Carried out filter integrity testing to ensure system sterility.
- Maintained high standards of cleanliness, with thorough area clearance and pre/post-use equipment wipe-downs.
- Maintained high standards of cleanliness, with thorough area clearance and pre/post-use equipment wipe-downs.
- Effectively managed inventory through stock checks and restocking of area Kanbans.
- Reviewed and verified batch records and SOPs, ensuring compliance and accuracy.
- Demonstrated strong teamwork capabilities, consistently contributing to achieving team objectives, and delivering results.
Cleanroom Production Operator
Hewlett Packard
01.2013 - 01.2018
- Demonstrated multitasking proficiency, consistently meeting production deadlines.
- Streamlined machine setup and process preparation for incoming tests, including documentation and Excel management.
- Proactively identified and resolved quality issues, implementing effective root cause solutions.
- Skilled in the routine maintenance of production equipment, minimizing downtime.
- Attended weekly planning and operation meetings to schedule upcoming experiments and evaluate tool and testing capabilities.
- Communicated experiment progress and updates to customers, ensuring transparency.
- Vigilantly maintained cGMP compliance through continuous safety and housekeeping supervision.
- Successfully solved a major production issue which improved production efficiencies, and reduction in scrap and machine downtime.
Education
L6 Certificate in Biopharmaceutical Processing -
NIBRT National Institute for Bioprocessing
08.2020
NIBRT Introduction to Biopharmaceutical Processing Unit Operations -
NIBRT
01.2017
Skills
- Competence in Microsoft Office
- SAP
- Problem solving
- Strong interpersonal skills
- Quality Control
- Aseptic Techniques
Accomplishments
- Awarded for managing high test lab work volumes, addressing escalations, and satisfying customer demands
- Acknowledged for significant contributions to sustainability, teamwork, and adaptability, processing 1,500 additional pens for weekly testing
- Celebrated by peers in the Living Our Values program for collaborative problem-solving in production
- Honored with the Operational Excellence Award for leadership in doubling inspection area throughput
- Recipient of multiple eAwards for exceptional quality focus and critical quality control interventions
- Championed the Yield Curator role and SAP reporting with unwavering dedication. Resolved a major production challenge, enhancing efficiencies, reducing scrap, and cutting machine downtime
Timeline
Manufacturing Process Technician
Amgen
12.2023 - Current
PQS Operator
BD Medical
01.2020 - 12.2023
Bioprocess Associate
Bristol-Myers Squibb
01.2019 - 01.2020
Cleanroom Production Operator
Hewlett Packard
01.2013 - 01.2018
L6 Certificate in Biopharmaceutical Processing -
NIBRT National Institute for Bioprocessing
NIBRT Introduction to Biopharmaceutical Processing Unit Operations -
NIBRT