Validation Engineer - Computer System Validation (CSV)

Req ID:  169066
Location: 

Ballina, IE, F26D786 Cambridge, GB, CB23 6DP Tranent, GB, EH33 2NE Dublin, IE, D09 Den Bosch (S-Hertogenbosch), NL, 5231 DD GB Ecully, FR, 69130 Cambridge, MA, US, 02139 Erkrath, NW, DE, 40699 Keele, GB, ST5 5SP Harrogate, GB, HG3 2XA

For 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.

 

 

Description

We are seeking an experienced Validation Engineer - Computer System Validation (CSV) to join our team in Europe. This role shall be aligned with the Ballina site in Co. Mayo, Ireland and shall be a hybrid role which will require a minimum of 2 days on-site each week.  

 

Reporting to the Director CSV Automation & Data Integrity, this role will provide oversight and implementation of validation activities associated with computerized systems to ensure compliance with applicable Good Manufacturing Practice (CGMP) regulations, Corporate policies, and site Standard Operating Procedures (SOP's). 


The successful candidate will work closely with the Operations and Quality departments to develop validation deliverables, ensuring fit for purpose and testing requirements that are defined, and are in compliance with the Master Validation Plan and applicable CGMP regulations.

 

The main duties of the Validation Engineer – Computer System Validation (CSV) shall be:-

  •     Prepare validation deliverables for computerized systems, including Validation Plans, Requirements Specification, Configuration Specifications, Risk Assessments, Test Scripts, Traceability Matrices, and Validation Summary Reports.
  •     Coordinate and schedule system vendors with respect to the execution of Installation, Operation, and Performance Qualification (IQ/OQ/PQ) protocols, and subsequent Re-Qualification (RQ) protocols if applicable for new and in-use equipment to ensure compliance with site procedures, Master Validation Plan (MVP), and regulatory requirements.
  •     Assist system SMEs in the preparation of test scripts comprising formal testing of functional, system and regulatory requirements in conjunction with computerized system validation. Oversee test script execution.
  •     Work with Operations and Quality to assess risk and impact with respect to proposed changes within the facilities and validated processes. Participate in meetings associated with the scheduling of these activities to ensure minimal impact to existing operations.
  •     Provide ongoing Qualification/Validation and other appropriate System Lifecycle training/education of staff.
  •     Provide ongoing support for Data Integrity projects to identify and ensure the safeguarding of data in compliance with site procedures, regulatory requirements, and corporate policies.
  •     Organize an efficient method to ensure all requirements of assigned validation deliverables are completed and that validation efforts are executed in a timely manner.
  •     Participate in the development of corrective actions as needed for deficiencies that may be uncovered/observed during validation efforts in regards to equipment, processes, test methods, facilities, computer software/systems, SOPs, and other related issues in order to assure compliance with applicable regulatory requirements/guidelines, procedures and policies.
  •     Participate in the development of CAPA’s and assess the effectiveness of the corrective action. Schedule validation project team meetings to assure project milestone schedules are maintained and deliverables satisfy requirements.
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  •     Assist as needed during client and regulatory audits and help to resolve or mitigate audit findings related to system qualification/validation

 

Requirements

 

The following are minimum requirements related to the Validation Engineer – Computer System Validation (CSV) position:

  •  
  •     BSc/MSc. in a relevant discipline (Scientific, Engineering, IT discipline or related field).
  •     5+ years’ experience in computerized system validation related experience in a pharmaceutical, biotechnology and/or biomedical industry. Working knowledge of lab equipment/instrumentation, test method, process, and facility validation in a regulated environment preferable.
  •     Must have excellent oral and written communication skills to regularly communicate with colleagues and clients and exchange accurate information.
  •     Strong documentation development and technical writing skills are critical to this position.
  •     Must have in-depth knowledge of accepted industry practices and the regulatory requirements that govern Computer System Validation in the pharmaceutical industry.21 CFR Parts 210, 211, 820, 11, EU Annex-11, and applicable ICH and FDA guidance’s.
  •     Must have good interpersonal, organizational, and analytical skills
  •     Proven track record in project management and have the ability to manage multiple projects
  •     Ability to problem solve and work on own initiative.
     

About Biologics Testing Solutions
With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterzation, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs.  Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.

 

About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

 

With over 17,000 employees within 90 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2018, revenue increased to $2.67 billion. 

 

At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of ~85% of the drugs approved by the FDA in 2019.