Computer Systems Validation Engineer

About the role

The Computer Systems Validation Engineer will identify and implement industry best practices through an extensive industry network and detailed knowledge of applicable regulations. During the scoping portion of these improvement projects, the person in this role will work with other experienced members of the CSV team to identify roadblocks and additional efficiencies.

Responsibilities

• Lead efforts between internal customers and CSV to ensure assigned activities are prioritized, communicated in an effective and timely manner, and completed on time.
• Accountable for maintaining full knowledge of Lonza's policies/procedures, 21 CFR Part 11, Data Integrity, ICH Q7A requirements and GAMP and the underlying principles of each.
• Perform all aspects of Quality Systems Management (QSM) processes (Change Control, Deviation, Corrective and Preventable Actions) as well as Validation Maintenance of computerized systems.
• Participate in audits and inspections as a Subject Matter Expert.
• Own, revise and maintain computer systems validation SOPs (Standard Operations Procedures).
• Function as CSV SME in Inspections and Audits.
• Mentor and train junior members of the department.

Requirements

• Bachelor’s degree required, preferred in computer science, engineering, or other sciences.
• Minimum of 5 years of experience working with automation and/or computerized system validations.
• Minimum 2 years’ experience with Controls Automation, Process Control Systems, Distributed Systems, Manufacturing Execution Systems (MES) required, DeltaV preferred.
• Prior experience leading or managing projects beneficial.
• CAPA and deviations experience desired.
• Biotech/Pharma/Medical Device/Medical or biologics industry experience required.
• Ability to work independently and meet deadlines successfully.

Qualifications

Biotech/Pharma/Medical Device/Medical or biologics industry experience required.

Skills

• Strong understanding of industry regulations and standards.
• Experience with Quality Systems Management processes.
• Knowledge of computerized systems validation and maintenance.
• Excellent communication and project management skills.
• Ability to work collaboratively and independently.

Benefits

Competitive salary and comprehensive benefits package. Opportunities for career development and advancement. Supportive and collaborative team environment. Access to cutting-edge technology and tools. Commitment to employee well-being and safety. Inclusive workplace culture. Recognition and reward for your contributions. Access to our full list of global benefits: here.

Pay

Competitive salary based on experience and qualifications.

Schedule

Full-time position.

Benefits

Comprehensive benefits package including health insurance, retirement plans, and paid time off.