- Develop and execute validation protocols for pharmaceutical equipment, including systems and software validation, in accordance with regulatory requirements such as FDA, EU GMP, and ISO standards.
- Collaborate with cross-functional teams including engineering, quality assurance, and regulatory affairs to ensure validation activities are completed effectively and efficiently.
- Perform risk assessments to identify potential hazards and develop mitigation strategies for validation activities.
- Conduct testing and analysis to verify that equipment meets performance specifications and functional requirements.
- Generate comprehensive validation documentation, including protocols, reports, and traceability matrices, ensuring accuracy and compliance with regulatory standards.
- Provide support during regulatory inspections and audits by presenting validation documentation and addressing any inquiries related to validation activities.
- Stay informed about industry trends and regulatory changes related to validation practices and implement best practices to continuously improve validation processes.
- Bachelor's degree in engineering, pharmaceutical sciences, or related field; advanced degree preferred.
- Minimum of 5 years of experience in developing validation plans and protocols within the pharmaceutical industry, preferably in equipment manufacturing or OEM environment.
- Strong understanding of regulatory requirements for pharmaceutical validation, including FDA 21 CFR Part 11, EU Annex 11, and GAMP guidelines.
- Proficiency in validation methodologies such as IQ/OQ/PQ, risk assessment, and validation lifecycle management.
- Experience with validation of complex systems and software applications used in pharmaceutical equipment.
- Excellent analytical and problem-solving skills, with the ability to troubleshoot technical issues and propose effective solutions.
- Exceptional communication skills, both verbal and written, with the ability to effectively collaborate with cross-functional teams and communicate complex technical concepts to non-technical stakeholders.
- Detail-oriented with a commitment to producing high-quality validation documentation that meets regulatory standards.
- Ability to work independently with minimal supervision and manage multiple projects simultaneously
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Validation Engineer - Warminster, United States - System One Holdings, LLC
Description
Title: Automation Validation Engineer - PharmaceuticalLocation: Warminster, PA
Type: 6 Month Contract potential for extension or hire
Schedule: Mon-Fri Day
Overview: Growing Pharmaceutical Company is seeking an Automation Validation Engineering Professional to develop and execute validation plans and tests for new pharma processing equipment. The ideal candidate will have a strong background in validation methodologies, experience in the pharmaceutical industry, and experience crafting processes and validation protocols.
Responsibilities:
