Salary Range: 110000 to 140000 (Currency: USD) (Pay period: per-year-salary)

Responsibilities

• Manage and lead the validation team, ensuring successful execution of all validation activities, including equipment qualification, computerized system qualification, process validation, and system implementation in compliance with regulatory standards.
• Develop, maintain, and manage the Validation Master Plan to ensure compliance with regulatory requirements and industry best practices.
• Direct and actively participate in equipment qualifications, process validations, and system implementations to ensure timely and compliant completion of projects.
• Collaborate with cross-functional teams to ensure that validation activities align with project timelines and objectives.
• Develop and implement templates and processes to optimize validation efforts, ensuring both compliance and operational efficiency.
• Write, review, and approve validation protocols, reports, risk assessments, trace matrices, and SOPs to meet regulatory and internal requirements.
• Stay current with industry practices and regulatory requirements, applying FDA 21 CFR Part 11, Annex 11, and other relevant guidelines to validation strategies.
• Serve as a key contact during internal and external audits, ensuring validation activities are audit-ready and compliant with regulatory standards.
• Responsible for presenting audit findings and maintaining a strong quality culture throughout the organization.
• Ensure that cleaning validation protocols and reports meet regulatory standards and support product quality and safety.
• Provide hands-on support for validation activities, including troubleshooting and complex investigations, ensuring ongoing compliance with the validation lifecycle.
• Develop and implement risk-based approaches for equipment validation, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
• Lead, mentor, and develop the validation team and stakeholders in validation best practices, promoting a culture of compliance and continuous improvement.
• Foster a collaborative work environment that encourages continuous improvement and innovation in validation practices.
• Stay current with industry regulations, standards, and best practices related to validation and quality assurance.

Qualifications

• Bachelor’s degree in a scientific or engineering discipline preferred.
• 5-10 years of experience in a pharmaceutical or cGMP-regulated environment, with hands-on experience in equipment and system validation.
• Strong knowledge of validation principles, risk assessments, and regulatory standards such as cGMP, 21 CFR Part 11, and Annex 11.
• Demonstrated leadership experience managing a validation team.
• Excellent technical writing skills, with experience in change control, deviation management, and regulatory documentation.
• Ability to manage multiple projects and work independently with a proactive, hands-on approach.