Miriam Naticchia
Lititz,USA
Summary
Detail-oriented packaging and aseptic production operator with hands-on experience in Grade A-D cleanroom environments. Supports formulation, filling, lyophilization, buffer preparation, Pupsit testing, and GMP-compliant operations while helping maintain inspection readiness. Knowledge of Annex 1 POFF. Trained in the use of packaging equipment and Secondment lead role.
Overview
1
1
Certification
38
38
years of professional experience
Work History
Operator
GSK
MARIETTA, PA
01.2010 - Current
- Executed operator tasks in Grade A-B aseptic areas and Grade C-D cleanrooms for MMR, Varilrix, and ASO3 adjuvant production within formulation, filling, and lyophilization.
- Operated vial washer, vial capper, and vessel equipment consistently.
- Qualified in 1V/1T buffer preparation and Annex 1 POF processes. Experienced with Pupsit filter integrity testing.
- Adapted quickly to changing processes in volatile pharmaceutical environment, including PUPSIT, Annex 1 POF, MMR to varicella, and ASO3 transitions.
- Assumed secondment lead responsibilities on packaging line, enhancing leadership and line performance.
- Coached newly hired workers on job tasks and facilitated SAP operation.
- Assisted FFL with FDA and regulatory inspection preparation through GMP1 inspection readiness.
- Completed qualification process in the MVI department in 2009 and the packaging department in 2010. Function in current role as Packaging Operator effective March 2026. Skilled on the Groninger, Dividella, Case packer, and Loading.
LPN
Nursing
LEBANON, PA
01.1989 - 05.2009
- Delivered comprehensive care for acute and long-term patients across hospital, nursing home, and private-duty settings, enhancing patient comfort and recovery.
- Prepared and administered medications via oral and intramuscular injections in a timely manner.
- Successfully managed the care of patients in isolation rooms, adhering to strict aseptic techniques and proper PPE.
- Administered CPR during emergencies and implemented effective comfort measures, ensuring patient safety and emotional support.
- Supported patients with activities of daily living (ADLs) and facilitated range of motion exercises, promoting independence and improving overall well-being.
Education
LPN - Nursing
05-2009
Skills
- Machinery operation
- GMP compliance
- Job training
- Problem-solving
- Attention to detail
- Teamwork and collaboration
- Strong work ethic
- Verbal communication
Certification
Train the Trainer, GSK, Fire Warden, GSK, CPR Certified, GSK, First Aid Responder, GSK, SME SAP, GSK, Culture Catalyst, GSK, Mental Health Matters, GSK, GSK Marietta Engagement team, GSK, MES Trained, Bosch SCADA Trained
Timeline
Operator
GSK
01.2010 - Current
LPN
Nursing
01.1989 - 05.2009