Key Responsibilities:
* Provide technical support to biologics, small molecule and combination medical device product packaging development at contract manufacturing organisations.
* Support troubleshooting efforts and high-level deviation investigations in conjunction with contract manufacturers and internal partners.
* Manage change controls and risk assessments executed in support of packaging development activities.
* Write technical documentation for packaging tech transfer protocols, packaging technical studies and user requirements specifications.
* Analyse packaging development data and provide input for regulatory agency submissions.
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Required Skills and Qualifications:
* Bachelor's degree in engineering or a similar technical qualification/equivalent experience in pharmaceutical or medical device packaging development.
* Understanding of good manufacturing practices (GMP) for biopharmaceutical manufacturing.
* Strong communication skills to present and influence.
* Organised analytical thinker with strong attention to detail.
* Excellent written and oral communication skills.
* Proficiency in Microsoft Office Suite.
* Experience working with systems within a GMP environment.