Job Title: Technical Specialist
About the Company: Our client, a leading Biopharmaceutical company, is seeking a highly skilled Technical Specialist to join their team in Cork. The facility specializes in fermentation, purification, and sterile filling of biotech products, as well as supporting product development and clinical trials.
About the Role: As a Technical Specialist, you will be responsible for:
* Authoring process change control documentation, technical communications, and process risk management.
* Providing technical oversight, management, and planning support for complex partnership models.
* Providing technical guidance to External Partners, assessing viability of technology in proposed process configurations, verifying adherence to required standards, and ensuring deliverables are technically sound.
* Leading teams for identification and assessment of partner risks and developing mitigation plans.
* Providing manufacturing process support to External Partner(s) to resolve production issues and provide guidance on process and capacity optimization.
About You: To be successful in this role, you will need:
* A Bachelor's degree in Engineering or applicable Science.
* An advanced degree in Engineering, Science, or Business (preferred).
* Minimum of 2-4 years post-bachelor's degree experience in pharmaceutical manufacturing, engineering, and/or technical support of operations.
* Experience in leading cross-functional teams in support of manufacturing operations at internal sites or External Partner(s) (preferred).
Requirements:
* You must hold a Stamp 1 G/Stamp 4 visa to apply.
* Ability to work from home.
Skills: Tech Transfer PPQ Process Improvements Lean 6