Senior Facilities & CSV Validation Lead

PCI TRGR Penn Pharmaceutical Services Ltd; Illinois; In loco; USD 109.000 - 123.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health insurance

401(k) plan

Paid time off

Flexible spending account

Descrizione del lavoro

PCI Pharma Services seeks a Facilities and Software Validations Manager to coordinate validation across facilities, ensuring cGMP compliance and robust validation systems. You will lead a team, design policies, and drive continuous improvement in validation programs.

The role requires 6–8 years in validation with expertise in CSV, GAMP 5, and FDA regulations, plus strong leadership and cross-functional collaboration. Competitive benefits are offered.

Competenze

• Bachelor’s degree in Engineering, Life Sciences, Computer Science, or related technical discipline.
• Minimum of 6-8 years of experience in facilities, utilities, and computer system validation in a regulated industry.

Mansioni

• Oversees Validation Supervisors and engineers; manages staff growth and development.
• Develops and maintains Validation Master Plan, policy, and practices.
• Plans, executes, and oversees validation of facilities, cleanrooms, and utilities (HVAC, water systems).
• Reviews and approves validation documentation (URS, IQ/OQ/PQ, risk assessments).
• Leads CSV activities per GAMP 5, FDA, ISO requirements.

Conoscenze

CSV validation

GAMP 5

FDA regulations

Staff supervision

Validation lifecycle

Quality & compliance

Formazione

Bachelor’s degree in Engineering/Life Sciences/CS

Descrizione del lavoro

PCI Pharma Services seeks a Facilities and Software Validations Manager to coordinate validation across facilities, ensuring cGMP compliance and robust validation systems. You will lead a team, design policies, and drive continuous improvement in validation programs.

The role requires 6–8 years in validation with expertise in CSV, GAMP 5, and FDA regulations, plus strong leadership and cross-functional collaboration. Competitive benefits are offered.