Summary
Overview
Work history
Education
Skills
References
Timeline
Generic

ALEENA SIBY

Liverpool

Summary

Accomplished professional with extensive expertise in pharmaceutical manufacturing, process validation, and regulatory compliance. Proven expertise in leading validation projects, optimizing sterile manufacturing processes, and implementing innovative solutions to improve efficiency and quality. Skilled in SIP validation, risk assessment, CAPA implementation, and continuous improvement. Adept at collaborating with cross-functional and external teams to drive process innovation and regulatory compliance (MHRA, FDA, EMA, GMP, GxP). Passionate about problem-solving, technology transfer, and data-driven decision-making in pharmaceutical environments.

Overview

7
7
years of professional experience
3
3
years of post-secondary education

Work history

Validation Specialist

Teva Pharmaceuticals
Runcorn
04.2023 - 07.2025
  • Led SIP (Steam in Place) validation for aseptic blow-fill-seal machines, mixing vessels, holding tanks, homogenisers, WFI vent filters, and associated piping (including new equipment qualifications and annual re-validation of 40+ systems).
  • Validated SIP for Bausch & Ströbel syringe filling machine (Grade A RABS).
  • Supported recipe scale-up and resolved API loss issues during scale-up by optimizing sterilisation parameters (introduced pulsing to prevent boil-over).
  • Reviewed engineering documents and batch-related deviations for packaging equipment such as Brevetti - visual inspection machine.
  • Supported Engineering in developing actionable defect parameters when original URS lacked trendable data, improving packaging rejection analytics.
  • Prepared, calibrated, and used Kaye Validator/Veriteq equipment (thermocouples, SIM wiring, pressure transducers, LTR heat block, IRTD).
  • Managed manufacturing issues related to SIP systems and conducted thermal mapping for Controlled Environments.
  • Authorised Test Person for Autoclave validation testing to BS EN 285 standards.
  • Conduct controlled environment studies.
  • Led investigations into process deviations, conducted risk assessments, and implemented corrective actions in timely manner.
  • Collaborate with cross-functional teams to resolve issues throughout operations and validation.
  • Reviewed protocols and documents, conducted data trending and statistical analysis.
  • Provided training and guidance to staff on SIP systems and best practices.
  • Led continuous improvement projects.
  • Led collaboration with Merck on aseptic sampling yield improvement project; hosted Merck’s roadshow and built key partnerships.
  • Trained in conduction Smoke Visualisation studies.

Sterile Specialist

Teva Pharmaceuticals
Runcorn
05.2022 - 04.2023
  • Manufactured in Grade C and Grade B environments utilizing aseptic techniques and cGMP.
  • Took an active role in troubleshooting and provided quick, effective solutions.
  • Assisted with development of new SOPs and improved existing ones by identifying inconsistencies.
  • Trained new starters and ensured their competency in sterile processes.
  • Reported instances of non-conformance to management and ensured compliance with cGMP by completing batch and associated manufacturing documentation accurately.
  • Competent in manufacturing using Aseptic filling machine (Optima) in the bottle filling line.
  • Operated Autoclaves and completed CIP and SIP of manufacturing/filling systems.
  • Demonstrated strong understanding of complex systems and processes in the pharmaceutical industry.
  • Completed Vessel entry qualification.

Communications Manager

Be Free Campaign
Liverpool
01.2019 - 01.2022
  • Directed teams in Fundraising, PR, Marketing, and celebrity/influencer management.
  • Focused on improving young people's mental health outcomes through dynamic team collaboration.
  • Managed budgets, staff, and projects to enhance mental health services and charity reputation.
  • Edited a self-help book released in Waterstones.

MEDICAL LAB ASSISTANT

Liverpool Clinical Laboratories
06.2020 - 07.2021
  • Conducted quality control checks on lab equipment ensuring accurate readings.
  • Competent in all stages of Sample Preparation according to Standard Operating Procedures and aseptic techniques
  • Trained new staff and Associate Practitioners.
  • Utilized ‘Telepath’ for accurate and efficient data entry.

Education

BACHELOR OF SCIENCE - BIOLOGICAL AND MEDICAL SCIENCES

University of Liverpool
01.2018 - 01.2021

Skills

  • Validation & Equipment Qualification (IQ, OQ, PQ, SIP)
  • Autoclave Validation (STM2 & STM3)
  • Sterile Manufacturing & Cleanroom Operations (Grade A/B/C/D)
  • Process Innovation
  • New Equipment Introduction
  • Technical Transfer
  • Risk Management (QRM)
  • CAPA Implementation
  • Cross-Functional Collaboration
  • Project Management
  • Continuous Improvement (Lean, Six Sigma)
  • Team Leadership and Management
  • Communication and Interpersonal Skills
  • Contractor & External Manufacturer Oversight
  • Regulatory Compliance (GMP, GxP, MHRA, FDA, EMA)
  • Deviation Investigations
  • Root Cause Analysis
  • Technical Documentation
  • Regulatory Submission Support
  • Packaging Process Support
  • Troubleshooting

References

References available upon request.

Timeline

Validation Specialist

Teva Pharmaceuticals
04.2023 - 07.2025

Sterile Specialist

Teva Pharmaceuticals
05.2022 - 04.2023

MEDICAL LAB ASSISTANT

Liverpool Clinical Laboratories
06.2020 - 07.2021

Communications Manager

Be Free Campaign
01.2019 - 01.2022

BACHELOR OF SCIENCE - BIOLOGICAL AND MEDICAL SCIENCES

University of Liverpool
01.2018 - 01.2021

Similar Profiles

Create profile
ALEENA SIBY