Overview
Senior Validation Engineer – Life Science and Engineering at Berkley Group.
The Validation department performs equipment, utility, facility, cleaning, and sterilization validation activities to ensure compliance with company procedures and industry standards in support of Operations and Quality Systems for Drug Product Manufacturing.
This role focuses on delivering the qualification and validation program, including planning and execution of validation/requalification activities on critical facilities and equipment, with an emphasis on cleanroom environmental monitoring qualification to support changes and expansion of the production environment.
There may be a requirement to work on shift to support critical project milestones.
Responsibilities
Provide technical validation support to meet site objectives, comprising the full validation lifecycle process.
Develop, review, and approve validation plans, protocols, discrepancies, and summary reports.
Lead the strategy development and associated risk assessments for Environmental Monitoring qualification.
Lead the planning and execution of environmental qualification activities in accordance with EU & FDA regulations including:
Environmental Qualification of Grade C cleanrooms
Environmental Qualification of Grade A Isolator Filling Lines
Support the execution of airflow visualization studies (smoke studies), filter integrity, velocity, and particle monitoring testing activities
Coordinate projects and prioritize workload in line with site priorities
Participate in multidisciplinary site and multisite teams, such as cross-functional investigation teams and change control
Collate and report relevant validation data and metrics
Assist in the development and improvement of the validation lifecycle process while ensuring compliance with all applicable regulations and Amgen standards
Provide validation support for Amgen's quality management system, including change control, deviation, and CAPA processes
Update and maintain validation SOPs in accordance with site and corporate requirements
Attend and contribute to staff meetings and training sessions as required
Comply with the responsibilities outlined in the Site Safety Statement and champion safe working practices
Perform all tasks with due care and attention in accordance with Good Manufacturing Practices and Amgen's requirements, policies, and procedures
Basic Qualifications
Bachelor of Science/Engineering degree or equivalent.
Microbiology qualification is desirable
Knowledge of cGMPs and other worldwide regulatory requirements
Problem-solving ability and excellent oral and written communication skills
5+ years' experience in a similar role
Preferred Experience
Experience qualifying cleanroom facilities and/or HVAC systems
Familiarity with Quality and Document Management Systems, including Maximo, Veeva, and Kneat
Independent, self-motivated, proactive, organized, able to multi-task in project environments, and skilled in communication and collaboration
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Consulting and Engineering
Industries
Pharmaceutical Manufacturing
Dublin, County Dublin, Ireland
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