Job Description
Job Description
We are seeking a Validation Engineer to provide continuity for the validation program in the assigned plant or functional area by writing, reviewing, and approving validation documentation. Other duties may be assigned.
Responsibilities:
- Document validation requirements to guide customers, regulatory Ensure compliance with the company's validation prograbodies, manufacturing plants, research & development, IT, and laboratory groups.
- Provide guidance on validation documents regarding content and format for validation life cycle documentation.
- Write protocols and reports related to QA, including statistical sampling plans, assessment criteria (Validation Rationale), compliance, guidelines, and specifications.
- Review and approve validation life cycle documentation, including change control documents, specifications, protocols, deviations, and reports.
- Offer support during protocol incident processes, including reporting, investigations, and resolution approvals.
- Utilise engineering, vendor, and customer specifications to create and execute testing protocols for equipment, following company and customer procedures and good documentation practices.
- Maintain attention to detail and a thorough understanding of pharmaceutical processes, automation processes, equipment, and systems.
- Stay up to date with industry-standard practices and FDA validation requirements.
- Write/revise validation templates and validation plans.
- Ensure deadlines for agreed projects are met.
Education:
- Minimum Bachelor of Science Degree in Engineering or Science.
Experience:
- 3-5 years of experience writing, approving, and executing validation protocols and reports, specifically in: Process Validation, Sterilisation, Equipment/Utility Qualification, and Computer System Validation.
- Strong understanding of computer systems applications and business/manufacturing processes.
- Excellent written and verbal communication skills, strong problem-solving abilities, and the capacity to work effectively both as a team member and leader.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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