Development Manufacturing Operator - Ireland
Manufacturing Operatives required for pharmaceutical manufacturer based in Dublin 15.
Development Manufacturing Operator (12 Month Fixed Term Contract)
The primary purpose of this role is to support the Manager, Product Development by operating machinery and carrying out tasks relating to manufacturing and packaging operations. Working within the Technical Affairs Department the Development Manufacturing Operator will assist with the manufacture and packing of Development & Clinical and potentially Commercial batches.
Principle duties involve the following:
Working as part of the team to strive to meet the manufacturing/development schedule.
Manufacturing and packaging of development, registration, clinical and if necessary, commercial batches.
Performing cleaning operations (Process Equipment and Facility)
Performing In Process tests.
Recording and completion of batch records and recording of critical process parameters in support of product development and commercialisation activities.
Requisitioning of materials and ensuring that adequate supplies of materials are available.
Informing the Team Leader or Manufacturing Supervisor immediately of any out of specification results or inefficiencies affecting manufacturing processes.
Performing minor maintenance on equipment and support maintenance and engineering in equipment troubleshooting where necessary.
Preparation of new SOPs and updating of current SOPs.
Ensuring manufacturing and development activities run smoothly and efficiently.
Implementing cGMP’s in all activities and to ensure that company SOP’s are implemented and adhered to.
The successful applicant must possess the following knowledge, skills, qualifications, attributes and experiences.
- A Leaving Cert or Equivalent
- At least 2 years manufacturing experience working within a cGMP Pharmaceutical manufacturing environment. (IMB/FDA approved)
- Experience of tablet manufacturing (I.E Granulation, Tableting or Coating) with sound knowledge of related machinery and their operations.
- Ability to troubleshoot and identify technical issues and follow up with corrective actions.
- The ability to work well with all key contacts, with a proven track record of being a team player/worker.
- Ability to work with short timelines and meet strict deadlines.
- Ability to write SOPs relating to the operation (ideally with proven experience of same)
Ideally, applicants will have a Higher Cert in Pharmaceutical Science along with in-depth understanding of cGMP Quality systems and their implication in a manufacturing context. Experience with handling potent products an advantage
The Helsinn Group
Helsinn is a privately owned pharmaceutical group with an extensive portfolio of marketed cancer care products and a robust drug development pipeline. The company is headquartered in Lugano, Switzerland, with operating subsidiaries in Switzerland, Ireland and the U.S., a representative office in China as well as a product presence in approximately 190 countries globally. Our mission is to bring respect, integrity and quality to our products, services, and all that we do to improve the health and quality of life in every person affected by cancer.
Helsinn Birex Pharmaceuticals, Dublin, Ireland.
This job is based at the Group's finished pharmaceutical manufacturing plant, Helsinn Birex Pharmaceuticals (HBP). HBP operates a state-of-the-art drug product development and manufacturing facility for the production of oral, solid and topical dosage forms. In addition, the company carries out final packaging of special dosage forms such as sterile forms and softgel which are produced by its worldwide network of CMOs. HBP also acts as the Group's supply chain platform, distributing the Group's products globally.
Over the years, we have been consistently recognized by industry awards both international and domestic, for industrial safety, responsible care and employee wellbeing.
Helsinn is an Equal Opportunity Employer and welcomes applicants who meet the above criteria. No recruitment agency assistance is required for this vacancy.