Pharma Validation Engineer — Equity Eligible

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

Job summary

CSL is seeking a Validation professional to plan, design, and execute qualification/validation activities in a cGMP environment. You will prepare Validation Master Plans, Project Plans, protocols and Final Reports while coordinating with cross-functional teams.

Responsibilities include maintaining validated state of manufacturing processes, performing risk assessments, and supporting regulatory interactions. Strong collaboration with Manufacturing, MS&T, QE, QA, and Reg Agencies is essential.

Qualifications

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

Responsibilities

• Execute validation activities on site.
• Ensure that all manufacturing processes on site remain in a validated state, including cleaning processes.
• Plan, communicate, and manage risk-based validation strategies for small to medium scale projects.
• Perform process strategy or cleaning risk assessments using defined risk management tools.
• Anticipate and troubleshoot issues in validation studies, equipment, and procedures.
• Coordinate with Manufacturing, Engineering, QC Labs and other groups on validation study requirements and status.

Skills

Listening

Action Oriented

Customer Focus

Time Management

Dealing with Ambiguity

Problem Solving

Drives results

Priority Setting

Education

Engineering or Biological Science degree

Job description

CSL is seeking a Validation professional to plan, design, and execute qualification/validation activities in a cGMP environment. You will prepare Validation Master Plans, Project Plans, protocols and Final Reports while coordinating with cross-functional teams.

Responsibilities include maintaining validated state of manufacturing processes, performing risk assessments, and supporting regulatory interactions. Strong collaboration with Manufacturing, MS&T, QE, QA, and Reg Agencies is essential.