LSC have a great contract opportunity for a Technical Writer (Engineering) to join an innovative and rapidly growing Biopharmaceutical company in Limerick. The facility is responsible for the production, packaging, labelling and delivery of biopharmaceutical medicines for global markets. The company currently markets medicines for various diseases and has a rich pipeline of products.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Provides support, information, and assistance to individuals, groups and management with the initiation, review, submission, and follow-up of documents such as Change Controls, EOE's, NOE's, DNF's, risk assessments, impact statements and corrective/prevention action plans. Will author technical evaluations, test plans & relevant lifecycle documentation.
- Facilitates reviews of and revises department related life cycle documents, SOP's, plans and policies for each group within the Department.
- Identifies opportunities for continuous improvement of compliance and leads improvement initiatives.
- Acts as a liaison between Engineering and onsite quality and regulatory groups to define and address compliance related items.
- Provides tracking and trending for maintenance of related compliance activities i.e., quality instances and PERs.
- Maintains knowledge of current good manufacturing practices (cGMPs).
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Direct experience and in-depth knowledge of biopharmaceutical equipment desirable (Solution Prep, Bioreactor, Centrifuge, Chromatography, UFDF) desirable
- Primary degree in Science/Engineering discipline and 3+ years of related experience working in a cGMP environment (biopharmaceutical desirable) or in the operation of an industrial facility. May substitute relevant experience in lieu of education.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Call Siobhan Cummins at LSC on 021 4777 329 to discuss this new role in detail or apply directly via this advert