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.
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
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.
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
