Validation Engineer

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A fantastic opportunity has arisen for a Validation Specialist. Our client, a state-of-the-art drug substance and drug product manufacturing facility based in Co. Louth, is seeking a Validation Engineer to support their team at the facility.
The jobholder works within the Global Engineering Team to act as client representative to deliver integrated project engineering services to meet the Project Objectives.
The Project Engineer will assist in the management of cross functional teams to deliver a portfolio of assigned projects.
This is a contract position, based fulltime onsite.
The role may require small periods of travel to support vendor reviews.

Core Duties and Responsibilities:

Support the site validation activities across a number of workstreams.
Develop and maintain the site Validation Master Plan.
Drive development of site EMPQ strategy and implement/maintain EM protocols and procedures for graded pharmaceutical areas, ensuring compliance with regulatory guidelines.
Perform/involved in risk-based EM assessments to determine the environmental monitoring requirements.
Oversee EMPQ validation studies, ensuring proper execution, data collection, and documentation.
Collaborate with production and quality control teams to establish EM procedures, sampling routines and requirements.
Draft, review and approve validation documentation, reports, and deviation investigations.
Periodic classification of areas/EM programs to ensure their ongoing effectiveness.
Support equipment qualification post Operational Qualification (OQ) through to Process Performance Qualification (PPQ) and subsequent revalidation.
Support global regulatory submissions, internal audits and external inspections/audits as needed.
Facilitate problem solving & risk assessment projects/meetings.
Making problems visible and strive for continuous improvement.
Lead and support various organizational initiatives as needed (examples include safety, financial forecasting, work standardization, etc).
Keep up to date with scientific and technical developments.
Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.

Education & Qualifications Required:

Bachelor’s degree (or higher) in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry etc.
3-5 years direct experience with a pharmaceutical or biotechnology company with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.
Prior experience in Cleaning Validation, Temperature Mapping activities, and qualification of Parts Washers and/or Autoclaves.
Experience with upstream cell culture and/or downstream formulation/fill finish processes.
Experience with technology transfer, regulatory filing, and commercial drug substance/drug product manufacturing of biologics. xcfaprz
Prior experience in drug substance/drug product, process performance qualification and validation, site readiness and authoring regulatory CTD sections.

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