Validation Engineer
7 days ago
Generation/maintenance/execution of Project Validation Plans and schedules.
Generation of validation protocols and final reports to c GMP standards.
Generation of validation investigations and implementation of corrective actions.
Creation/Review/Approval of various quality documents and test data.
Management of validation, exception event, and change control processes.
Maintenance and tracking of validation equipment, if applicable.
Completing all required training before executing a task.
Documenting all activities in line with c GMP requirements.
Updating of validation procedures, job instructions and batch documentation to reflect current best practices.
Requirements Qualification and/or degree in engineering or scientific discipline.
Experience Required 3 years plus of knowledge of c GMP, validation and regulatory requirements relating to the biopharmaceutical industry.
Strong communication (written and oral), presentation and troubleshooting skills required Effective interpersonal and organizational skills.
Ability to work well both independently and in a team environment.
Capable of prioritizing work and multitasking.
Additional Requirements This role is accountable for supporting a positive developmental culture with the organization while ensuring compliance with Quality policies.
Requires good knowledge of Company Policies and Procedures and involves working towards general results to achieve organizational needs.
May be required to support Cross functional teams and cost improvement projects.
Persuasion and direction skills required to convert thinking of others where gathering acceptance is difficult but important to job performance.
This position impacts manufacturing, product quality, and technical performance of the product produced at the site location.
Decision making within confines of agreed responsibility.
Activities broadly defined by agreed goals and company competencies with general management oversight.
Close contact with Personnel within the plant at all levels.
Close contact with internal and external auditors, e.g.
FDA, IMB Interaction with other site and TPM personnel in cross-functional Activities.
For further information please forward your CV Skills: Pharmaceutical Validation Quality Management c GMP Requirements
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