Job Type: Contract
Job ID: JO-1901-12381
Consultant: Karen McHugh
Are you an Manufacturing Engineer with 5+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality) ?
If interested in this role, call Karen on +353 17978720 for more information.
Manufacturing Engineer - Amgen - Dublin
Our Client is Amgen and the role will be based in their Dun Laoghaire plant.
The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
Develop, review and update production Standard Operating Procedures.
Develop, review and update master/generic batch records, bills of materials etc.
Develop, review and update Product Quality Risk Assessments.
The Manufacturing Specialist will also function as the Manufacturing point of contact on New Product Introduction (NPI) Projects and be responsible for:
Partnering with key functional groups to drive strategy definition for risk assessments, characterization, validation, regulatory, and filing milestones.
Lead Product Team meetings.
Ensure compliance with project milestones such as conformance batches manufacturing, regulatory submissions, and product launches
Hold people to account for delivery and behaviors within Product team
Function as the site interface between the Product Delivery Teams (PDT’s), and ADL Senior Management.
Author, Reviewing and Approving new training materials.
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.
Use specified software packages and standard procedures, responsible for compiling and maintaining all relevant documentation including batch documentation, bills of materials and SOP’s for submission to the Product Lead.
Provide technical and clerical support to the production team in the preparation of documentation, collation of data.
Own and lead change controls as required by the NPI Project Team.
Bachelor's Degree in Science or Engineering and 5+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality)
OR Associate's Degree in Science or Engineering and 8+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality)
10+ years directly related experience in a biotech/pharma manufacturing or manufacturing environment
Detailed technical understanding of fill/finish operations
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
12 month minimum contract
€30 - €40 per hour
Karen McHugh is the consultant managing this position.
If you have any queries about this role, you can contact her by e-mail firstname.lastname@example.org or phone +353-1 7978720
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