Technical Shift Lead

HERO

Job Detail

Location Sligo
Salary Negotiable
Posted
Role Type Permanent
Contact Laura Neary
email recruit@hero.ie

Technical Shift Lead

Apply Now

Job ID: JOB-12179

Finding the right company that aligns to your career aspirations and values is so important. It’s worth taking the time to get this right.

This Technical Lead job opportunity located in Sligo is one of those stand out positions that don’t come along every day.

Let us tell you more….


Job Purpose:

My client is now recruiting for a Technical Shift Lead (Biologics) to be part of their extended leadership team in their Sligo site. Reporting directly to the Operations Lead, you will be lead, and coach your team and be responsible for producing biologics fill finish materials as per organizational needs in line with all relevant safety and quality compliance requirements.

Responsibilities:

  • Lead, coach and mentor your team
  • Be responsible for the supervision and execution of filling, lyophilization, equipment preparation, formulation, buffer preparation and support processing activities in the biologics fill finish facility to meet clearly stated operating objectives.
  • Promote a culture of contamination control and compliance with aseptic best practice.
  • Liaise with functional leadership teams (Ops, Quality, Engineering, Supply Chain etc) on operational activities
  • Daily reporting on the status of all operations and support activities.
  • Provide clear and concise communication to your team on their tasks and goals so that they can work effectively.
  • Provide technical expertise for investigation and resolution of process deviations, root cause investigation, CAPAs, process improvements, review and approval of change controls
  • Responsible for verification and update of manufacturing control system transactions accurately and in a timely fashion.
  • Act as key point of technical contact for aseptic fill finish activities.
  • Liaise with program management, supply chain, technical operations quality and engineering groups to ensure effective planning, scheduling and execution of commercial and NPI clinical manufacturing.
  • Responsible for driving operations excellences and Key operations targets including OEE where applicable.
  • Provide direct interface as a subject matter expert with QA department to interaction with HPRA, FDA and applicable health authority and internal audits.
  • Lead cross functional risk assessments and continuous improvement projects
  • Ensure the execution of fill finish, lyophilization, equipment preparation, buffer preparation and formulation processing activities to meet clearly stated operating objectives.
  • Responsible for manufacturing compliance with all safety, environmental and quality related SOPs.
  • Drive safety improvements and initiatives across the operation
  • Promote a culture of Right First Time, Behavioural Based Safety, Always Audit Ready and Human Error Reduction within their team.
  • Work closely with the other Technical Shift Leaders to ensure interdepartmental activities are planned and executed safely.

Requirements:

  • You will have a Degree, Masters or PhD in Life Sciences, Process Engineering, Biopharmaceutical Engineering or Chemical Engineering discipline
  • With 5 + years’ experience in batch processing, automation, commissioning and validation in an FDA/HPRA regulated industry and 1+ years team leadership experience
  • Detailed knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required for this role.
  • Comprehensive understanding of the principles of contamination control and regulatory expectations for aseptic processing.
  • Has a technical background in pharmaceutical, biologics, or similar industries
  • Experience of start-ups and/or new product introductions to bio-pharmaceutical/pharmaceutical facilities (Biologics Preferred)
  • Demonstrated project management skills, including the ability to deliver projects on schedule, within budget, and meeting the predefined quality and safety requirements.

For further information on this role please contact Laura Neary on 086 773 8651/ recruit@hero.ie 

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/ 

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Laura Neary

JOB-12179

Apply Now

Technical Shift Lead

Laura Neary

Role Type Permanent
Contact Laura Neary
email recruit@hero.ie
mobile +353 86 773 86 51
linkedIn profile click here

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