Quality Engineer - Validation
Posted on: November 11, 2019
Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company
and a leader in a new industry model - Growth Pharma. Allergan is
focused on developing, manufacturing and commercializing branded
pharmaceutical, device, biologic, surgical and regenerative
medicine products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class
products for the central nervous system, eye care, medical
aesthetics and dermatology, gastroenterology, women's health,
urology and anti-infective therapeutic categories. With commercial
operations in approximately 100 countries, Allergan is committed to
working with physicians, healthcare providers and patients to
deliver innovative and meaningful treatments that help people
around the world live longer, healthier lives every day.
Allergan is a company that will inspire you to aim high with your
ambition. Where you can build bridges all over the world. Where you
can power ideas that drive change. And where you will act fast and
drive results for customers and patients. Power your future & join
our bold team.
The Quality Engineer, Validation, supports the Quality Laboratories
with the qualification cycle of equipment and computer systems.
Main Areas of Responsibilities
- Maintains the validation timeline and status for validation
- Manages the activities of validation consultants utilized to
assist in the implementations.
- Develops and communicates project timeline and status.
- Develops and reviews validation documents and implementation
documentation that supports required validation activities.
Documents include Validation Project Plan, Requirements and
specifications, vendor Evaluation Documentation,
Installation/Operational/Performance Protocols and Final
- Provides technical assistance, training and work direction to
other staff members.
- Writes protocols that challenge the critical parameters related
to installation, operation, and performance of the related
facility, utilities, computer systems or equipment, and assures
that protocols are approved through proper channels.
- Executes validation and qualification protocols per related
SOPs and assures that acceptance criterion related to validation
and qualification protocols are met.
- Interacts with all affected personnel in the execution of
protocols and gathering of test data.
- Ensures that all test data is gathered and recorded in
accordance with cGxP requirements and industry trends.
- Carries out responsibilities in accordance with the
organization's policies and procedures, state, federal and local
- Performs related duties as assigned.
- Previous experience with Waters LC equipment and Empower,
Mettler Toledo equipment and LabX, Lonza MODA, and other QC
Chemistry and QC Microbiology equipment is ideal.
- Current Good Manufacturing Practices (cGMP), Food and Drug
Administration (FDA), United States (USP) and European (EP)
Pharmacopeias, and related federal, state and local laws, codes,
regulations and regulatory requirements.
- Experience with validating QC Laboratory systems.
- Pharmaceutical quality control processes.
- Principles and practices of GAMP 5 qualification and
- Techniques of sampling, testing and measuring, and principles
of mathematical and statistical computations.
- Pharmaceutical principles, practices and applications.
- Personal computer operations and Microsoft applications (Word,
Project, and Excel).
- Knowledge of management systems and enterprise-type
- Relevant experience ? five (5) years preferred.
- Validation experience ? three (3) years preferred.
- Intermediate Microsoft Office Skills.
- Experience with Empower, MODA,LabX, QMS and Trackwise
- Experience working in a GMP regulated environment
- Bachelor's degree in a science, engineering, or related field
from an accredited college or university, and three (3) to thirteen
(13) years progressively responsible related experience preferably
within the food, cosmetic or pharmaceutical industries.
Keywords: Allergan, Waco , Quality Engineer - Validation, Other , Waco, Texas
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