Validation Engineer

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

Position Purpose:

Plans, communicates, and leads scientifically sound strategies for small to medium scale validation projects in a cGMP environment. Designs, schedule, and execute scientifically sound qualification/validation experiments which demonstrate compliance with regulatory requirements, product license restrictions, and industry standards under the guidance of the Validation Lead and Sr. Validation Managers. Prepare and approve Validation Master Plans, Project Plans, protocols, and Final Reports. Represent the Validation department on cross-functional and/or global project teams. Interacts with Manufacturing, MS&T, M2U, ExS, QE, QA, QC, R&D, and Regulatory Agencies.

Main Responsibilities and Accountabilities:

1. Accountable for executing validation activities on site:

• Accountable for ensuring that all manufacturing processes on site remain in a validated state, including cleaning processes.
• Plans, communicates, and manages scientifically sound, risk-based validation strategies for small to medium scale multi-facetted projects.
• Responsible for performing process strategy or cleaning risk assessments for the site manufacturing processes using defined risk management tools.
• Able to anticipate, recognize and trouble shoots problems associated with validation studies, equipment, and procedures.
• Effectively schedules and communicates with appropriate functional groups (i.e. Manufacturing, Engineering, and QC Labs, etc.) in regards to validation study execution/testing requirements and status of assigned execution activities.
• Responsible for leading and performing process strategy or cleaning risk assessments for the site manufacturing processes using defined risk management tools.
• Responsible for providing input to deviations related to validation activities: support of the root cause analysis and CAPA definition as required.

2. Support Validation Programs and Compliance of Regulatory guidances:

• Oversees writing and reviewing of documents for required registrations and providing adequate responses to regulators regarding validation topics.
• Responsible for applying validation procedures to ensure compliance with global standards and regulatory guidelines.
• Identification and closure of validation gaps on site to minimize compliance risks.
• Can support internal and external inspections for all validation related topics.
• Liaises/aligns with the other site teams and the CoE on validation topics.
• Responsible for providing input to and agreeing on new or changes to relevant validation concepts, procedures, policies, standards.
• Ensures the implementation and execution of the defined validation strategy considering optimization of costs and effort (e.g. with innovative and risk-based approaches).
• Drives continuous improvement and innovation for validation processes on site in close collaboration with the CoE.

Requirements

Education:

• Degree in Engineering, Physical or Biological Science preferred.
• Proven demonstration to perform in the role may also be considered.

Experience:

• 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.
• Experience with team dynamics. Demonstrated skills in interpersonal communication, delegation, and decision making.

Competencies:

• Listening
• Action Oriented
• Customer Focus
• Time Management
• Dealing with Ambiguity
• Problem Solving
• Drives results
• Priority Setting

The expected base salary range for this position at hiring is $72,000 - $82,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable