Title: Automation Validation Engineer - Pharmaceutical
Location: 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:

• 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.

Qualifications:

• 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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