Manufacturing Specialist - Dun Laoghaire
CK Group are recruiting for a Manufacturing Specialist to join a global Bio-tech in Dun Laoghaire. The role will be offered on a 12 month contract initially and is full time.
Our client is one of the worlds leading manufacturers of biosimilar and biopharmaceutical products used in the treatment of a wide range of human healthcare conditions from cancer to arthritis. This company are a strong believer in helping patients by developing new treatments and taking them to market via their global network of specialist aseptic manufacturing, packaging and distribution sites.
This role is located on a state of the art manufacturing facility based in Dun Laoghaire and is a quick 30 minute drive away from the centre of Dublin, or 60 minutes drive from Dublin Airport. The site is easily commutable from Kildare or Wicklow by car and there is a good public transport network if you would prefer to live within Dublin itself. Dun Laoghaire is a vibrant cultural hub in south Dublin which is best known for its maritime history and locally caught sea food.
The Manufacturing Specialist will function as the manufacturing point of contact for NPI projects.
Responsibilities would include the following: • Partnering with key functional groups to drive strategy definition for risk assessments, characterization, validation, regulatory, and filing milestones.
- Ensure compliance with project milestones such as conformance batches manufacturing, regulatory submissions, and product launches
- Function as the site interface between the Product Delivery Teams (PDT's), and Senior Management.
- Develop, review and update Protocols for manufacturing activities.
- Documentation and approval of protocol deviations for manufacturing activities.
- Perform Job Hazard Assessments and Change Control Assessments to determine impact to Manufacturing.
- Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current SOP's, batch documentation and licences.
- Liaise with Process Development regarding documentation changes in an effective and timely manner.
To be considered for the role, you will be required to have the following skills, knowledge and experience:
- Degree qualified or equivalent in a relevant engineering or scientific subject
- Detailed technical understanding of fill/finish operations
- Significant experience in the pharmaceutical or biologics industry is essential
- Experience participating in and leading cross-functional teams
- Experience in managing multiple, competing priorities in a fast-paced environment
- Strong technical writing and presentation skills
- Ability to be flexible and manage change
- Ability to communicate and collaborate with technical and management staff
- Project Management experience
For more information or to apply for this position, please contact Alex at CK Group on 01246 457 718 or email email@example.com. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference KA44277 in all correspondence.