The Role & What You Will Be Doing

Every day, we rise to the challenge to make a difference and here’s how the Validation Specialist role will make an impact:

• Process Validation/Qualification projects will be across a range of production areas which may include Process, Cleaning, Software, Utility and Facility projects.
• Generation, execution and close out of validation projects relating to existing products and new product introductions.
• Accountable for writing, executing & reporting of all validation activities including but not limited to (FAT / IQ / OQ / PQ / FMEA Risk Assessments/ PVP).
• Participate in project teams and assist in determining project schedules and the appropriate levels of validation.
• Execution and documenting risk assessments (FMEA) with respect to validation activities.
• Perform validation functional testing as required. Track and resolve deviations during qualification activities.

About Your Skills & Experience

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• Bachelor's degree in Science, Engineering, Technology or a related discipline.
• Hands-on experience working as a validation engineer/specialist in a cGMP environment, preferably in an oral solid dose facility.
• Full understanding of cGMP requirements, including Annex 11 and Annex 15.
• Effective technical writing skills.
• Excellent interpersonal, leadership, communication (written and verbal) and time-management skills.
• Flexible and able to manage multiple priorities simultaneously.
• 
  

The Role & What You Will Be Doing

Every day, we rise to the challenge to make a difference and here’s how the Validation Specialist role will make an impact:

• Process Validation/Qualification projects will be across a range of production areas which may include Process, Cleaning, Software, Utility and Facility projects.
• Generation, execution and close out of validation projects relating to existing products and new product introductions.
• Accountable for writing, executing & reporting of all validation activities including but not limited to (FAT / IQ / OQ / PQ / FMEA Risk Assessments/ PVP).
• Participate in project teams and assist in determining project schedules and the appropriate levels of validation.
• Execution and documenting risk assessments (FMEA) with respect to validation activities.
• Perform validation functional testing as required. Track and resolve deviations during qualification activities.

About Your Skills & Experience

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• Bachelor's degree in Science, Engineering, Technology or a related discipline.
• Hands-on experience working as a validation engineer/specialist in a cGMP environment, preferably in an oral solid dose facility.
• Full understanding of cGMP requirements, including Annex 11 and Annex 15.
• Effective technical writing skills.
• Excellent interpersonal, leadership, communication (written and verbal) and time-management skills.
• Flexible and able to manage multiple priorities simultaneously.