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Validation Project Manager

Charles RiverBallina, Mayo

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.

Reporting to the Facilities Manager, this role will be responsible for the management of all Site Validation activities on various laboratory equipment sets. Validate/qualify equipment, systems and processes in accordance with Site/Regulatory requirements and support, follow and implement company standards policies and procedures.

Responsibilities

    • Generate & execute validation protocols and reports as required.
    • Responsible for writing, executing & reporting of all validation activities including but not limited to (VP/ DQ / FAT / IQ / OQ / PQ / ARF’s / Deviations).
    • Execution of validation studies including thermal qualification of equipment
    • Process qualification including all areas of the validation life cycle.
    • Responsible for planning and coordinating validation schedules on site and efficient execution of both short and long-term projects.
    • Analyses the results of testing and determines the acceptability of results against pre-determined criteria.
    • Responsible for all associated validation documentation compliant with GMP.
    • Prioritize qualification activities in line with the project schedule.
    • Provide input into all project phases i.e. from design through to the commissioning and qualification execution phases of the project.
    • Resolve and assist in the closure of deviations initiated during qualification / validation execution.
    • Generation, execution and close out of validation projects relating to new and existing equipment.
    • Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
    • Participates in project teams and assists in determining project schedules and the relevance of appropriate levels of validation.
    • Execution and documenting of process risk assessment / failure mode and effects analysis.
    • Represent validation at internal and external audit.

The following are minimum requirements related to the Validation Project Manager position:

  • A minimum of 3 years’ experience in the Pharmaceutical Industry
  • Strong communication and writing skills
  • Good time management and planning skills
  • Although not a requirement, experience of any of the following would be an advantage:
    • Thermal Mapping of controlled temperature units.
    • Laboratory equipment validation
    • Sterilisation validation of autoclaves
    • Commissioning, Qualification & Validation of new systems
    • Utility qualification
    Knowledge Skills & Abilities:
    • * Ability to maintain integrity and honesty at all times * Ability to work independently or as part of a team * Ability to communicate with transparency * Continuously drive to improve processes for improved performance * Demonstrate respectful behaviour at all times * Basic working knowledge of Microsoft Suite (Word, Excel, PowerPoint) * Gathers and organizes information * Meets commitments on time * Follows directions; performs well-defined tasks * Effective time management skills * Seeks to identify continuous improvement needs

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 14,000 employees within 80 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 by 22% to $2.27 billion from $1.86 billion in 2017.

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 2018.

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