4 days ago Be among the first 25 applicants
Get AI-powered advice on this job and more exclusive features.
Direct message the job poster from Berkley Group
Recruitment Consultant - Life Science and Engineering at Berkley Group
Operations Lead
Operations Lead will serve as primary production process owner responsible for New Product Introduction, Life Cycle Management Projects and/or CAPEX projects and established process improvements projects. This role requires in-depth technical and operational knowledge of aseptic Drug Product manufacturing processes; Parts/Components Preparation, Formulation, Syringe Filling, Vial Filling, Lyophilisation and Capping.
They will be the operations point of contact for coordination of the manufacturing effort and will be responsible for driving process efficiencies as part of the project for operations.
They will apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to ensure streamlined manufacturing operations are enabled in both vial and syringe facilities.
Responsibilies:
* Function as the site interface between the Product Delivery Teams (PDT's), and ADL Manufacturing operations.
* Engaging with staff members within the Manufacturing department to ensure understanding of the processes and working collaboratively cross functionally with Facilities & Engineering, Quality, PD and Supply Chain.
* Develop, review, and approve Generic Master Batch Records and Parameter Value Lists across
* Formulation, Filling and Inspection
* Develop, review and update Production, Engineering, Operating Procedures & training materials
* Assist in providing training on scientific or technical aspects of the current process/project(s) to Direct Manufacturing
* Evaluate, plan, and implement solutions for process improvement opportunities both current and project related.
* Support scheduling and execution of Characterisation, Engineering and PPQ runs, ensuring all necessary pre-requisites are included on the schedule and assess process performance by observation of floor operations and review of performance data
* Provide troubleshooting support throughout the project and on the floor during execution of activities
* Hold people to account for delivery and behaviors within the Manufacturing Support team and associated with the project(s)
* Perform Job Hazard Assessments and Change Control Assessments to determine impact to
* Manufacturing
* Partner with Learning & Performance to define training strategies for current processes, NPIs and complex projects
* Consult with Quality Assurance to ensure that GMP standards are maintained in line with current SOP's, batch documentation and licences
* Develop, review and update Protocols for manufacturing activities
* Documentation and approval of protocol deviations for manufacturing activities
* Consult with Process Development, Direct manufacturing, Equipment, and System Owners regarding process changes in an effective and timely manner
* Own and lead change controls as required by the Manufacturing support team
* Review and approve Bills of Materials
* Develop, review and update Product Quality Risk Assessments
Basic Qualifications:
* Bachelor's degree in a science discipline.
* 3+ years of biopharmaceutical manufacturing experience in Fill Finish or related manufacturing or GMP experience in the pharmaceutical or medical device industry.
* Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
* Strong Project Management and organizational skills, including ability to follow assignments through to completion
* Critical thinking skills: Gathers data from key stakeholders, analyses and interprets information to develop solutions to technical problems of moderate complexity
Shift Patterns & On-Call Opportunities:
Now they have a lot of PPQ activities coming up due to the new vile line we'll be asking for volunteers for a 3-to-4-week period for the PPQ's. There will be volunteers to go on the two-cycle shift pattern & then the other ask is, if you're not going on the shift pattern can you do on-call for the weekends.
People required to go on a two-cycle shift pattern for the duration of each PPQ activities:
* 8 hour days operating over a 5 day week (Monday - Friday).
* 2 week rota.
* Week 1 Morning Shift: 07:00 - 15:00 (Mon - Thurs) 07:00 - 14:00 (Fri).
* Week 2 Evening Shift: 14:30 - 22:30 (Mon - Thurs) 13:30 - 20:30 (Fri).
* Alternating pattern, so if on morning shift week 1 then on evening shift week 2 and so on.
* 20% shift premium applied.
On-Call
* On-call cover for weekends from 07:00 Saturday - 19:00 Sunday (excluding nights).
* Rostered on-call.
* Must be able to attend site if required over both days.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Contract
Job function
* Job function
Engineering, Manufacturing, and Other
* Industries
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Berkley Group by 2x
Get notified about new Operations Lead jobs in Dublin, County Dublin, Ireland.
Dublin, County Dublin, Ireland 1 week ago
Manager, Global Response Operations (GRO) Detection
Dublin, County Dublin, Ireland 1 week ago
Learn Fast, Lead Faster – Join our team!
Dublin, County Dublin, Ireland €43,000.00-€64,000.00 2 weeks ago
Dublin, County Dublin, Ireland 3 weeks ago
Ashbourne, County Meath, Ireland 1 week ago
Dublin, County Dublin, Ireland 4 days ago
Dublin, County Dublin, Ireland 4 days ago
Dublin, County Dublin, Ireland €90,000.00-€110,000.00 2 weeks ago
Logistics Managers Leverage Your Leadership & Problem Solving Skills
Dublin, County Dublin, Ireland 1 month ago
Dublin, County Dublin, Ireland 6 days ago
Dublin, County Dublin, Ireland 2 weeks ago
EMEA Sales Strategy Planning & Operations Lead
Dublin, County Dublin, Ireland 1 week ago
Dublin, County Dublin, Ireland 7 hours ago
Dublin 12, County Dublin, Ireland 1 week ago
Content Operations Team Lead, Play and Android
Dublin, County Dublin, Ireland 2 weeks ago
Dublin, County Dublin, Ireland 2 months ago
Dublin, County Dublin, Ireland €65,000.00-€70,000.00 2 weeks ago
Dublin, County Dublin, Ireland 2 months ago
Dublin, County Dublin, Ireland 2 weeks ago
Dublin 2, County Dublin, Ireland 1 week ago
Dublin, County Dublin, Ireland 2 weeks ago
Dublin, County Dublin, Ireland 1 week ago
Dublin, County Dublin, Ireland 4 days ago
Senior Manager Supply Chain Inventory & Operations
Dublin, County Dublin, Ireland 2 days ago
Dublin, County Dublin, Ireland 2 months ago
Email Operations Manager (Ireland, Remote)
Dublin, County Dublin, Ireland 7 months ago
Senior Operations Manager- Capital Markets
Dublin, County Dublin, Ireland 3 days ago
Dublin, County Dublin, Ireland 4 days ago
Digital Manufacturing Technology Delivery Lead
Dublin, County Dublin, Ireland 3 days ago
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr