Validation Engineer

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 $72000 - $82000. 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 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

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients needs by using the latest technologies we discover develop and deliver innovative therapies for people living with conditions in the immunology hematology cardiovascular and metabolic respiratory and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation recombinant protein technology and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 people and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL CSL Behring CSL Seqirus and CSL Vifor visit and CSL Plasma at Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being CSL.

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At CSL Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy we are able to better understand and connect with our patients and donors foster strong relationships with our stakeholders and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process please visit Experience:

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