Senior Validation Lead, GMP & Sterilization Systems

Grifols; Los Angeles (CA); On-site; USD 160,000 - 190,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401(k) match

Paid time off

Tuition reimbursement

Job summary

Grifols is seeking an Associate Director of Validation in California to lead the GBIs Validation program, ensuring equipment, utilities, processes, facilities, and manufacturing systems meet cGMP and quality standards.

The role directs validation strategy, reviews protocols, manages priorities, collaborates with R&D, QC, Eng and Manufacturing, and supervises validation staff, while supporting a 24/7 plant operation in the Los Angeles area.

Qualifications

• Bachelor's degree in Computer Science, Engineering, Biology, Chemistry, Biochemistry, Physical Science, or related discipline; Master’s/PhD preferred.
• 6 years of Validation experience in pharmaceutical GMP/FDA environment; 4+ years in management.
• Deep understanding of validation principles and qualification requirements for sterilization and aseptic processing.
• Solid knowledge of cGMPs and FDA regulations; leadership experience is preferred.
• Proven ability to inspire performance and manage projects in a team setting.

Responsibilities

• Direct GBIs Validation program in line with GMP and quality standards.
• Develop validation strategy and policy to streamline validation.
• Review and approve validation protocols and reports to meet regulatory requirements.
• Prioritize validation projects with emphasis on critical ones.
• Coordinate validation documentation for regulatory submissions.
• Lead and develop Validation personnel and manage staffing needs.
• Oversee Validation Master Plans/Schedules and respond to audits.
• Collaborate with R&D, Quality Control, Engineering, and Manufacturing.

Skills

Validation experience

Leadership

Project management

Analytical skills

Communication skills

MS Office

Education

Bachelor's degree in related field

Master's degree preferred

Tools

GxP systems

Job description

Grifols is seeking an Associate Director of Validation in California to lead the GBIs Validation program, ensuring equipment, utilities, processes, facilities, and manufacturing systems meet cGMP and quality standards.

The role directs validation strategy, reviews protocols, manages priorities, collaborates with R&D, QC, Eng and Manufacturing, and supervises validation staff, while supporting a 24/7 plant operation in the Los Angeles area.