Job Type: Contract
Job ID: JO-2104-26149
Consultant: Karen McHugh
Do you have 5+ years of experience in a protein, API, DS, DP or packaging manufacturing environment?
Are you an experienced project manager with change control and deviation management experience?
If you have the relevant experience, send your CV to firstname.lastname@example.org or call +353-1-7978720 for a confidential chat.
Project Manager - Change Control - CMO - Biotech - WFH - Dublin
Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoighaire, South Dublin.
The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
This is an excellent opportunity to get experience into Ireland's leading aseptic manufacturing plant.
Contractors have a history of either extending their contract or being offered permanent positions on this site.
Provide information insight and data analysis, drive execution of transactional/tactical tasks to ensure Amgen Contract Manufacturing (ACM) work cell (hub) success.
Manufacturing operations: Ensure accuracy and completion of data entries and/or tasks for budget development, monitoring, and reporting; inputs to contracts, confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc.
Own NC Class II/III records, CAPA, CAPA EV, and more complex change control records.
Site performance monitoring: Report contract site performance metrics to site lead; identify improvement opportunities for site performance; daily duties will include coordination, issuance, and review of meeting minutes, conclusions from analysis of data and metrics, continuous improvement and standardization of performance tools used by the Work Center Teams (WCT), oversight and reporting of procurement/payment of invoices, and active participation in WCT meetings with the contract site as well as internal site team.
Project Management and Technology transfers: Follow-up and track activities in a department-wide project from conception to implementation and close-out.
Manage timeline and highlight risks of transfer team activities; coordinate risk management activities as part of transfer; provide escalation to the right level.
5+ years of experience in protein, API, DS, DP or packaging manufacturing environment
5+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles
2+ years of project management experience leading multi-functional and/or multi-location team
1+ years of experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products
Candidates needs to have change control and deviation experience is a must
Demonstrated matrix management and influencing skills.
Manufacturing and cGMP knowledge / experience.
Demonstrated negotiation skills.
Operational Excellence proficiency and ability to drive continuous improvement.
Financial/budgeting knowledge and business acumen.
Proficient project management skills.
Problem-solving and critical thinking.
Understanding of contractual requirements.
Technical writing and multi-level communication skills.
Demonstrated ability to lead effectively in collaborative/team environment.
Demonstrated ability to take initiative, drive action, and work under minimum supervision.
Hourly Rate €40 - €50 per hour
Minimum contract duration: 18 months
Karen McHugh is the consultant managing this position.
If you are Project Manager interested in roles based in Dublin, you can contact Karen by e-mail at email@example.com or phone +353-1-7978720 for a confidential chat.
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