Validation Specialist III

About the role

The Validation Specialist III is a senior-level professional responsible for leading the development, review, and execution of complex validation protocols supporting manufacturing, quality, and regulatory compliance. This role provides advanced technical expertise and strategic guidance on equipment, process, system, and computer system validations in accordance with cGMP, FDA regulations, and industry standards such as GAMP.

Responsibilities

• Lead the development, execution, and review of complex validation protocols, including computer system validation, manufacturing equipment qualification, packaging equipment validation, and lyophilizer qualification.
• Author, maintain, and approve comprehensive validation master plans ensuring full compliance with regulatory requirements and industry standards such as FDA, cGMP, GAMP, and EU GMP Annex 11.
• Oversee and conduct validation testing activities, analyze data for accuracy, reliability, and compliance, and prepare detailed final reports with recommendations for adjustments or corrective actions.
• Lead cross-functional collaboration to coordinate and integrate validation activities with production and quality teams, ensuring projects meet timelines with minimal disruption.
• Provide expert technical guidance and mentorship on new equipment installations, system modifications, and validation best practices to junior and mid-level validation staff.
• Drive continuous improvement initiatives focused on enhancing validation processes, procedures, and documentation standards.
• Manage relationships with external vendors and consultants to support validation projects and ensure adherence to quality and compliance standards.
• Support regulatory inspections and audits by preparing documentation, responding to inquiries, and addressing validation-related observations.
• Develop and deliver technical training and support to personnel on validation methodologies, regulatory expectations, and quality standards.
• Participate in special projects and perform additional duties as assigned by management to support departmental goals and organizational objectives.

Requirements

• Lead the development, execution, and review of complex validation protocols, including computer system validation, manufacturing equipment qualification, packaging equipment validation, and lyophilizer qualification.
• Author, maintain, and approve comprehensive validation master plans ensuring full compliance with regulatory requirements and industry standards such as FDA, cGMP, GAMP, and EU GMP Annex 11.
• Oversee and conduct validation testing activities, analyze data for accuracy, reliability, and compliance, and prepare detailed final reports with recommendations for adjustments or corrective actions.
• Lead cross-functional collaboration to coordinate and integrate validation activities with production and quality teams, ensuring projects meet timelines with minimal disruption.
• Provide expert technical guidance and mentorship on new equipment installations, system modifications, and validation best practices to junior and mid-level validation staff.
• Drive continuous improvement initiatives focused on enhancing validation processes, procedures, and documentation standards.
• Manage relationships with external vendors and consultants to support validation projects and ensure adherence to quality and compliance standards.
• Support regulatory inspections and audits by preparing documentation, responding to inquiries, and addressing validation-related observations.
• Develop and deliver technical training and support to personnel on validation methodologies, regulatory expectations, and quality standards.
• Participate in special projects and perform additional duties as assigned by management to support departmental goals and organizational objectives.

Qualifications

• Bachelor’s degree in Computer Engineering, Physical Sciences, or relevant field of study.
• Minimum of five (5) years validation related work experience.
• Knowledge of regulatory requirements, including FDA regulations, ISO 9000-3, PIC/S guidelines for cGMP, and GAMP 4 and 5 based on the GAMP V-Model Framework, as well as EU GMP Annex 11 for computer systems compliance.

Skills

• Strong knowledge of cGMP, FDA regulations, and industry standards such as GAMP.
• Expertise in developing and executing validation protocols.
• Ability to lead cross-functional teams and manage project timelines.
• Strong technical writing and reporting skills.
• Experience with regulatory inspections and audits.
• Ability to mentor and guide junior validation staff.
• Effective communication and problem-solving skills.

Benefits

• Generous benefit options (eligible first day of employment).
• Paid training, vacation and holidays (vacation accrual begins on first day of employment).
• Career advancement opportunities.
• Education reimbursement.
• 401K program with matching contributions.
• Learning platform.
• Additional benefits listed in the job description.

Pay

Competitive compensation package based on experience and qualifications.

Schedule

Full-time position with flexible scheduling options.