0830 Cleaning Validation and Qualification Support
Relative Cleanability Studies.
Support lab coupon studies to determine the cleanability new tech transfer products are compared to current products.
Experience with lab scale studies and data analysis.
Support pilot plant cleanability studies.
Support equipment qualification due to equipment modifications for tech transfers.
Tech transfer activities – Writing Cleaning Confirmation or Validation Protocols and Reports.
Execution of protocols by performing visual inspections, documentation (rinse samples by mfg).
Any deviations, anomalies or schedule impacting items are to be reported to site management.
This position provides trained technical resources for the development and execution of validation protocols in accordance with OCN and global procedures.
The person will maintain up-to-date training status in the Cornerstone (or equivalent) system.
This position provides resources for the controlled collection, assessment and reporting of scientific validation or study data in support of validation of processes.
The data will be analyzed using algebraic and/or statistical methods to verify adherence to predetermined and approved process criteria.
Reports will be written to communicate the outcome of the studies and/or validations.
This position will provide sampling and inspection support for process equipment as part of the validation execution process.
As such, the person must be trained on sampling and inspection procedures; and may be called upon to
provide training for others as needed.
Knowledge and application of basic validation and risk management theories, principles and techniques used in biopharmaceutical manufacturing is highly desirable.
Highly self motivated and able to work independently and as part of a multi-disciplinary team.
Outstanding attention-to-detail, time management, prioritization, and organizational skills.
Solid interpersonal, communication, and technical writing skills.
As with any position in a manufacturing environment, the job requires an ability to adapt to rapidly changing priorities and the flexibility to support operations in accordance with the manufacturing schedule.
The candidate must have work experience in a GMP regulated environment and an understanding of biopharmaceutical processes, equipment and facilities with demonstrated advanced knowledge of cleaning validation for at least one biopharmaceutical unit operation.
Specific knowledge in column packing and purification is a plus.
Previous experience large scale cleaning validation.