Validation Specialist

We are seeking a detail-oriented and experienced Validation Specialist to join our production manufacturing team. This role is critical in supporting our production processes by reviewing and approving essential validation documents. The contractor will be responsible for drafting, redlining, and authoring Standard Operating Procedures (SOPs), as well as assisting in the preparation and execution of Installation Qualification (IQ) and Operational Qualification (OQ) processes.

The ideal candidate will possess a strong background in validation within regulated environments, such as pharmaceuticals, biotechnology, or medical devices, and production manufacturing experience is a plus. This role will play a key part in ensuring that our production operations meet the highest standards of quality and compliance.

• Review and approve validation documents, including User Requirement Specifications (URS), Design Input Assessments (DIAs), Installation Qualifications (IQs), Operational Qualifications (OQs), IQ/OQ Reports, and deviation reports.
• Ensure all documents meet regulatory requirements and internal quality standards.
• Collaborate with stakeholders to draft new SOPs and update existing ones to reflect current practices and regulatory changes.
• Redline documents to suggest improvements and ensure clarity, accuracy, and compliance.
• Assist in preparing for the execution of IOQs by coordinating schedules and ensuring that all required materials, equipment, and documentation are ready and available.
• Support the execution of IOQs by coordinating with relevant teams and ensuring all activities are documented as per protocol.
• Work closely with cross-functional teams, including Quality Assurance, Engineering, and Production, to gather necessary information and insights for documentation.
• Maintain open lines of communication to address any issues or concerns related to validation documentation.
• Stay updated on industry regulations and best practices to ensure compliance across all documentation processes, with a specific emphasis on Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Identify areas for improvement in documentation processes and contribute to initiatives aimed at enhancing efficiency and effectiveness.
• Provide training and support to team members on documentation standards and best practices as required.

• Bachelor's degree in Life Sciences, Engineering, or a related field. Advanced degrees are a plus.
• Minimum of 1-3 years of experience in validation documentation within a regulated industry (pharmaceuticals, biotechnology, or medical devices).
• Proven experience in reviewing and authoring URS, DIAs, IQs, OQs, and SOPs.

• Strong understanding of validation processes and regulatory requirements (e.g., FDA, EMA).
• Excellent attention to detail and ability to work independently and collaboratively.
• Proficient in document management systems and Microsoft Office Suite.

• Strong analytical and problem-solving skills.
• Excellent written and verbal communication skills.
• Ability to manage multiple tasks and meet tight deadlines.