Lead CSV Engineer — Cell Therapy & GMP Data Integrity

Cellipont Bioservices; The Woodlands (TX); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

401K strong employer match

Tuition reimbursement

Flexible work schedules

Employee referral bonuses

Job summary

Cellipont Bioservices is hiring a Lead CSV Engineer in The Woodlands, Texas. This role is crucial for developing strategies in CSV for computerized systems, ensuring compliance with regulatory requirements, and leading cross-functional teams.

The ideal candidate should have a BS in a relevant field, at least 6 years of industry experience, and expertise in risk-based validation and data integrity.

Cellipont offers opportunities for career growth, a robust benefits package, and a chance to work in the transformative field of cell therapies.

Qualifications

• 6+ years of experience in the biopharmaceutical or regulated pharmaceutical industry.
• Experience in cell therapy, gene therapy, biologics, or aseptic manufacturing preferred.
• Strong knowledge of computerized system lifecycle management.

Responsibilities

• Lead CSV strategy and execution for GMP computerized systems.
• Define and execute testing strategies for system changes.
• Collaborate with cross-functional teams to coordinate project activities.

Skills

Risk-based validation

Data integrity

Change control

Regulatory compliance

Education

BS in Engineering, Computer Science, Life Sciences or related field

Tools

Smartsheet

Excel

Job description

Cellipont Bioservices is hiring a Lead CSV Engineer in The Woodlands, Texas. This role is crucial for developing strategies in CSV for computerized systems, ensuring compliance with regulatory requirements, and leading cross-functional teams.

The ideal candidate should have a BS in a relevant field, at least 6 years of industry experience, and expertise in risk-based validation and data integrity.

Cellipont offers opportunities for career growth, a robust benefits package, and a chance to work in the transformative field of cell therapies.