Commissioning & Qualification Engineer

16 May 2017
06 Jun 2017
Justin Pankinas
Job Type
Job Description
Our client is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, they are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.

Their ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, they strive to create an environment of mutual respect, encouragement and teamwork. As part of their global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

Technical Specialist Sterile Integrated Process Team (IPT)
*Responsible for performing the validation of equipment, utility systems, facilities, processes and/or automation systems for projects.
*Contributes directly to the completion of validation projects through the development of validation schedules, master plans, validation protocols and reports for systems that may be complex in nature, to support clinical and commercial manufacturing.
*Approve change controls as appropriate.
*Represents the department on cross-functional project teams.
*Understanding of the concepts of BioTech manufacturing would be desirable.
*As required, assists in preparation of regulatory submissions and presents validations in respective SME areas to regulatory authorities during routine internal and pre-approval inspections.

*Degree or 3rd level qualification (Science, Engineering, Process)
*Have at least 1-2 years' experience in the Pharmaceutical industry or a similar operating environment with experience in a Technical/Validation role in a manufacturing environment.
*Have Troubleshooting and analytical mind-set with an understanding of regulatory and validation requirements.
*Working knowledge of equipment and systems specifically Autoclave or cleaning validation is an advantage.
*Ability to interact with multiple stakeholders.
*Excellent verbal, written, and interpersonal communication skills are required.

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