API Technical Shift Lead

Team Horizon is seeking a Technical Shift Lead with API experience for a leading Pharmaceutical company in Sligo.

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.


• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.


• Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

• Supervision and execution of pharmaceutical processing activities in the API building and support locations, to meet clearly stated operating objectives.


• Daily reporting on the status of all operations and support activities.


• Team leadership, motivation and direction to maximize the effectiveness of their manufacturing team. The Technical Shift Leader must clearly communicate task details and goals to their team members, to allow the pharmaceutical technicians to work effectively.


• Responsible for verification and update of manufacturing control system transactions accurately and in a timely fashion.


• Act as key point of technical contact for API Business Unit. Shift technicians report directly to this role.


• Communicate the departmental goals, to provide cost effective products as part of the Class A supply chain system.


• Liaise with Supply chain & program management group to ensure effective planning, scheduling and execution of commercial and NPI clinical manufacturing.


• Resolves operations/project issues by working with team members, project customers, and others as appropriate.


• Responsible for driving operations excellences and Key operations targets including OEE where applicable.


• Ensure the execution of pharmaceutical processing activities in the API building and support locations, 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.


• Ensure successfully review, amendment and implementation of changes to SOPs and managing CAPAs.


• Promote a culture of perfect performance and Enhanced Right first time within their team.


• Liaise with the relevant departments & customers in the introduction and execution of NPIs Projects.


• Adheres to and supports all EHS & E standards, procedures and policies.


• All other duties as requested or assigned.

What you need to apply:

• Degree, Masters or PhD in Life Sciences or a Process/ Chemical Engineering discipline.


• Minimum of 5 year’s experience in batch processing, automation, commissioning and validation in an FDA/HPRA regulated industry.


• 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.


• Technical background in engineering, formulations and technical transfers capacity.


• A minimum of 1 year team direct supervisory experience in a team environment.


• Possess a strong technical knowledge and application of concepts, practices, and procedures.


• Works on problems of complex scope where analysis of situations or data involves multiple competing factors.


• Exercises judgment and advises management as to the appropriate actions.