BioPharma Senior Manufacturing Analyst

AbbVie

Westport, Ireland

Job Description

In the role, you will have the opportunity to organize and plan all aspects of operations and manufacturing technicians to execute a schedule defined by Supply Chain and/or other customers. You will ensure that all activities in the area comply with EHS and quality regulations. The role will be responsible for providing support to Manufacturing Technicians and Technical Shift Leads (TLSs) in achieving the overall business goals and objectives for the site. The Senior Manufacturing Analyst will communicate regularly with alternate shifts and other Departments such as Microbiology Lab, Maintenance, QA, Contamination Control Operators (CCO’s) and others.

In your new role you will:

Plan and schedule activities for Manufacturing Technicians, ensuring that all aspects of the area are fully staffed and that any constraints are managed appropriately or escalated to the TSL
Schedule activities in a multi-product facility, switching between product campaigns seamlessly
Ensure all activities are completed in line with regulatory (QA & EHS) and corporate requirements
Triage and troubleshoot equipment issues as they arise, escalate to maintenance
Actively lead and/or participate in Root Cause Analysis of non-conformances, equipment issues, environmental monitoring out-of-limits and complaints as they arise. Engage other Departments to resolve issues as required
Using skills matrix for Operations Team, drive cross-training to ensure performance of team and individuals
Lead and support continuous improvement initiatives as required to support the overall goals of Core 1
Promote and develop a culture of Right First Time
Provide leadership at Tier meetings to ensure focus is maintained on key objectives for the shift
Compile metrics as required for Perfect Index and others
Review and contribute to technical documents, including protocols, reports and batch manufacturing documents
Other duties as assigned

Qualifications

Education and preferred experience:

Bachelor’s degree in a related scientific field is required; and/or a minimum of 4 years’ experience in aseptic manufacturing environment. Must have experience in aseptic techniques, formulation, aseptic filling of sterile product and/or visual inspection of Parenteral products
Detailed knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required for this role
Comprehensive understanding of contamination control principles
Possess strong technical knowledge and application of concepts, practices, and procedures
Good interpersonal skills to develop working relationships with people at all levels
Previous people management experience is desirable

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