GMP Validation Engineer – Process & Compliance Leader

CSL Vifor; Bradley (IL); On-site; USD 72,000 - 82,000; Full time

Job summary

CSL Vifor in Bradley, IL is seeking an on-site Validation professional to lead scientifically sound qualification/validation activities in a cGMP environment. You will design, schedule, and execute validation experiments, author Master Plans, Protocols, and Final Reports, and collaborate with Manufacturing, MS&T, QE, QA, Regulatory Agencies, and other cross-functional teams.

Qualifications include a degree in Engineering or physical/biological sciences, 0-3 years’ experience in pharmaceutical

Qualifications

• Degree in Engineering, Physical or Biological Science preferred.
• 0-3 years’ experience in pharmaceutical manufacturing quality or operations management in a cGMP environment.
• Experience with current US and international regulations, industry guidance and best practices for the qualification/validation of facilities, utilities, equipment and process support commercial manufacturing preferred.
• Demonstrated interpersonal communication, delegation, and decision making skills.

Responsibilities

• Execute validation activities on site and ensure manufacturing processes remain validated, including cleaning processes.
• Plan, communicate, and manage risk-based validation strategies for small to medium scale projects.
• Perform process strategy or cleaning risk assessments for site manufacturing processes using defined risk tools.
• Anticipate and troubleshoot issues in validation studies, equipment, and procedures.
• Coordinate with Manufacturing, Engineering, QC Labs, and other groups on execution requirements and status.
• Provide input to deviations related to validation activities and support root cause analysis and CAPA.
• Oversee writing and reviewing documents for registrations and responses to regulators on validation topics.
• Ensure compliance with global standards and regulatory guidelines through validation procedures.
• Identify and close validation gaps to minimize compliance risks; support inspections.
• Collaborate with other site teams and CoE on validation topics; contribute to new/changed validation concepts, procedures, policies, standards.
• Drive continuous improvement and innovation for validation processes on site with CoE.

Skills

Listening

Action Oriented

Customer Focus

Time Management

Dealing with Ambiguity

Problem Solving

Drives results

Priority Setting

Education

Engineering, Physical or Biological Science degree

Job description

CSL Vifor in Bradley, IL is seeking an on-site Validation professional to lead scientifically sound qualification/validation activities in a cGMP environment. You will design, schedule, and execute validation experiments, author Master Plans, Protocols, and Final Reports, and collaborate with Manufacturing, MS&T, QE, QA, Regulatory Agencies, and other cross-functional teams.

Qualifications include a degree in Engineering or physical/biological sciences, 0-3 years’ experience in pharmaceutical