Validation & Equipment Compliance Lead

Chiesi Farmaceutici S.p.A.; Parma; On-site; EUR 52,000 - 65,000; Full time

Benefits offered by this job

Annual bonus

Pension

Private medical insurance

Wellbeing programme

Relocation support

Job summary

Chiesi Farmaceutici S.p.A. is seeking a Validation & Equipment Compliance Manager in Parma to lead the site validation program for equipment, processes, utilities, and computerized systems, ensuring data integrity and regulatory compliance.

The role includes budget oversight, workforce planning, and development of staff within Quality Operations Italy. Ideal candidates possess 8–10 years in pharma manufacturing, strong EU/FDA regulatory knowledge, and demonstrated leadership across

Qualifications

• Bachelor’s or Master’s Degree in a scientific or engineering discipline (e.g., Chemistry, Pharmaceutical Chemistry and Technology, Engineering).
• Minimum 8–10 years of experience in pharmaceutical or biopharmaceutical manufacturing environments.
• Extensive experience in validation and qualification of equipment and systems within cGMP-regulated environments.

Responsibilities

• Provide Quality oversight and formal approval for qualification and validation activities in full compliance with regulatory requirements.
• Lead and control the site Validation Program, covering equipment, processes, utilities, facilities, computerized systems, and instruments.
• Ensure Data Integrity compliance across all site computerized systems via CSV activities.
• Manage personnel in compliance with labor laws, safety regulations, and corporate policies.
• Support Site Quality in investigation of complaints and quality events and implement CAPA plans.
• Drive continuous improvement and participate in regulatory inspections and audits.

Skills

Quality oversight

Budgeting

Team leadership

Regulatory knowledge

Data integrity

Problem solving

Cross-functional collaboration

Education

Bachelor’s or Master’s degree in science or engineering

Job description

Chiesi Farmaceutici S.p.A. is seeking a Validation & Equipment Compliance Manager in Parma to lead the site validation program for equipment, processes, utilities, and computerized systems, ensuring data integrity and regulatory compliance.

The role includes budget oversight, workforce planning, and development of staff within Quality Operations Italy. Ideal candidates possess 8–10 years in pharma manufacturing, strong EU/FDA regulatory knowledge, and demonstrated leadership across