Computer system validation project manager - europe - united kingdom, tranent, east lothian

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.

we are seeking an experienced computer system validation (csv) project manager to join our team in europe. this role, whilst aligned with the ballina, co. mayo site can be either site based or worked remotely within europe.

reporting to the associate director, instrumentation optimization this role will be responsible for building and maintaining the project management framework for charles river validation projects. the main duties shall be:-

* coordinate with other departments to ensure all aspects of each projects are achieved

* provide guidance to operational areas on processes with global validation (master validation plan)

* manage multiple projects and assist operational groups in the development of validation deliverables and use of project management tools.

* write and assist in writing all validation deliverables within the computer system lifecycle, e.g. validation plans, summary reports, configuration specifications

* responsible for developing and revising test validation procedures/protocols in accordance with appropriate regulatory agency validation requirements, corporate & site quality management system and current industry practices

* manage the full lifecycle of validation projects including defining and monitoring multiple project deliverables and timelines in parallel

* maintain and provide project timelines and statuses in project management tool.

* coordinate project meetings, steering committees, workshops and production of related documentation i.e. minutes of meetings, project plans etc.

* assist other biologics sites, domestic and global, in response to their validation requirements as required

* participate in multi-site csv initiatives through document development or other validation activities

* ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures [sops, safety procedures and biosafety protocols].

* performs analyses and validate benefits related to selected projects.

* the following are minimum requirements related to the csv project manager position. *

* bsc/msc. in a relevant discipline.

* 5+ years' experience in validation & project management. experience is preferable within the pharmaceutical/medical device/cro industry but is not essential.

* project management certification preferable.

* ability to manage multiple projects

* ability to problem solve and work on own initiative.

* proven communication and organizational skills required.

*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.

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