Christine Tang
Round Hill,VA
Summary
Dynamic professional with 11 years of experience in validation and process controls within the biopharmaceutical industry, adept at navigating complex challenges. Strong problem-solving skills and a proactive approach to creating opportunities for continuous improvement and operational efficiencies. Committed to fostering a diverse team environment that aligns with shared goals and drives collective success. Passionate about contributing to innovative solutions that enhance productivity and quality in the field.
Overview
14
14
years of professional experience
Work History
Senior Automation Engineer
AstraZeneca Pharmaceuticals
Frederick, MD
12.2018 - 06.2026
- Managed automation efforts for Rockwell Automation supported major facility shutdown, fulfilling role of automation workstream lead on multiple capital expenditure and operating expenditure projects across different process areas, achieving completion of all projects on schedule for 2024 return-to-service dates.
- Led, developed, and implemented automation testing frameworks to enhance software quality and reliability.
- Managed automation contractors and led cross-functional teams to streamline automation processes
- Designed and implemented the Automation Event Log tool, a continuous improvement initiative that standardized incident capture and reporting, replacing manual work orders, Excel spreadsheets, and email drafts with a streamlined form-based workflow that improved communication and reduced rework.
- Served as Automation SME for multiple technology transfer product campaigns providing end-to-end and recipe testing support for Upstream and Downstream PCS areas, conducting simulator investigations to mitigate issues prior to campaign launch.
- Served as secondary automation on-call support for 24/7 facility.
- Collaborated with stakeholders to define process requirements and enhance end-user experience.
- Designed and implemented process control solutions, reducing manual intervention needs.
- Collaborated with cross-functional teams to identify process bottlenecks, process improvements, investigate deviation root cause, implement CAPAs
- Developed and executed automation validation protocols and functional test cases to enhance automation reliability and performance across multiple projects.
- Responsible for maintaining and updating automation specifications and SOPs.
- Presented project progress updates to stakeholders at regular intervals, maintaining strong communication channels throughout development cycles.
- Responsible for automation requests for proposals and managed automation workstream purchase orders
- Developed project plans, timelines, and resource allocation strategies for multiple projects.
- Mentored junior engineers and interns
Controls Systems Developer
Matrix Technologies, Inc.
Frederick, MD
01.2017 - 12.2018
- Automation Validation Contractor at AstraZeneca Biologics Division
- Authored and executed IOQs on development systems
- Investigated, troubleshot, resolved, and reported defects found during testing to determine root cause
- Collaborated with senior automation engineers, process engineers, and developers to rectify programming or design issues
- Peer reviewed of executed IOQs for good documentation practices
- Provided technical support/knowledge of systems and equipment during specification modifications
- Assisted in user interface design
- Validation representative during Factory Acceptance Testing (FAT)
- Managed and completed quality system change management tasks such as change controls, CAPAs, and deviations
- Managed automation specification lifecycle from redline to approved document
- Experience in Rockwell FactoryTalk, SQL, and iFix
- Understanding of Structured Text and Ladder Logic
Automation Validation Contractor
Aerotek
Frederick, MD
12.2014 - 12.2016
- Contracted at MedImmune, Biologics Division of AstraZeneca
- Authored and executed installation operation qualification (IOQ) protocols for modifications to the Upstream, Downstream, and Utilities control systems such process, CIP,and SIP phases to align with detailed design specifications
- Managed and oversaw pre-approval and post-approval processes of IOQs through document management program
- Collaborated with senior automation and process engineers to resolve test defects. Coordinated with external contractors to troubleshoot programming design and document source challenges.
- Responsible for training new contractors
Clinic Assistant
Jeffrey Y.H. Chung, M.D.
Laurel and Gaithersburg, MD
07.2012 - 12.2014
- Performed and operated optical coherence tomography machine, Humphrey visual field tests, pretests on vision and eye pressure efficiently to optimize patient experience and overall schedule
- Assisted in clinical procedures such as intravitreal injections, fluorescein angiography, pneumatic retinopexy procedures
- Executed administrative tasks, including data entry for electronic medical records. Managed billing and accounts receivable to ensure accurate financial tracking. Scheduled patient appointments to optimize clinic efficiency. Organized patient charts and verified insurance benefits and prior authorizations. Assisted on the implementation and transition from paper medical record to electronic medical record.
Education
Bachelor of Science - General Biology
University of Maryland, College Park
12-2011
Skills
- Project management experience
- Control systems
- Computerized System Validation
- Process design
- Process improvement
- Continuous improvement
Timeline
Senior Automation Engineer
AstraZeneca Pharmaceuticals
12.2018 - 06.2026
Controls Systems Developer
Matrix Technologies, Inc.
01.2017 - 12.2018
Automation Validation Contractor
Aerotek
12.2014 - 12.2016
Clinic Assistant
Jeffrey Y.H. Chung, M.D.
07.2012 - 12.2014
Bachelor of Science - General Biology
University of Maryland, College Park