Are you a Process Engineer with a solid background in API Manufacturing? We have a role with excellent career development opportunity to management level in under 2 years for someone with drive and ambition, to lead a rigorous continuous development programme.
API Process Engineer - Shift Leader - Sligo
Job Description:
To lead and facilitate the safe operations of the API manufacturing team in a pharmaceutical processing facility in line with all safety, regulatory and operational requirements.
Responsibilities
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 maximise the effectiveness of their manufacturing team. The Technical 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 Excellence 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 successful 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.
Work closely with the other Technical Shift Leaders to ensure interdepartmental activities are planned and executed safely.
Develop direct reports by securing appropriate training, assigning progressively challenging tasks and managing mid-year and annual reviews.
Assist and cooperate with HR in the management of employee relations issues.
Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures.
Maintains personnel records on Kronos and makes modifications in the database to reflect actual changes.
Assist in the identification, implementation and execution of key API and Site Strategies.
Schedules human and material resources within a department or section in conjunction with near-term plans to ensure their availability; carries out operations within an established budget
Requirements
Degree, Masters or PhD in Life Sciences or a Process/ Chemical Engineering discipline
A minimum of 5 years’ experience in batch processing, automation, commissioning and validation in an FDA/IMB regulated industry.
Detailed knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required for this role.
Background as a technical leader in a process engineering, formulations or technical transfer capacity.
Experience of start-ups and/or new product introductions to pharmaceutical facilities. Must be able to lead & project manage these activities.
Demonstrated project management skills, including the ability to deliver projects on schedule, within budget, and meeting the predefined quality requirements. Previous exposure to supply chain & schedule delivery in a manufacturing environment.
A minimum of 1 year previous experience of supervising a team environment with active participation in proactive improvement programs
Suitable direct supervisory experience or training.
Package:
€55K-€65K based on relevant prior experience
Permanent staff position
Shift rotations over 15 day cycle, (morning, afternoon, nights - 24hr operations)
25% Shift allowances
Comprehensive Medical plan
Defined Benefits Contributory Pension
21 days holidays
Canteen on site
Very active sports & social club
Contact
Sheila McNeice is the consultant managing this position. If you have any queries about this role, you can contact her by e-mail Karen@jobcontax.com or phone +353-91-395625
Click to connect with Karen on LinkedIn
Similar Roles
Biotech / Pharma / Medical Device Jobs in Ireland
Amgen Jobs - Dublin
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Jobs in Cork
Jobs in Lime
Are you a Process Engineer with a solid background in API Manufacturing? We have a role with excellent career development opportunity to management level in under 2 years for someone with drive and ambition, to lead a rigorous continuous development programme.
API Process Engineer - Shift Leader - Sligo
Job Description:
To lead and facilitate the safe operations of the API manufacturing team in a pharmaceutical processing facility in line with all safety, regulatory and operational requirements.
Responsibilities
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 maximise the effectiveness of their manufacturing team. The Technical 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 Excellence 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 successful 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.
Work closely with the other Technical Shift Leaders to ensure interdepartmental activities are planned and executed safely.
Develop direct reports by securing appropriate training, assigning progressively challenging tasks and managing mid-year and annual reviews.
Assist and cooperate with HR in the management of employee relations issues.
Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures.
Maintains personnel records on Kronos and makes modifications in the database to reflect actual changes.
Assist in the identification, implementation and execution of key API and Site Strategies.
Schedules human and material resources within a department or section in conjunction with near-term plans to ensure their availability; carries out operations within an established budget
Requirements
Degree, Masters or PhD in Life Sciences or a Process/ Chemical Engineering discipline
A minimum of 5 years’ experience in batch processing, automation, commissioning and validation in an FDA/IMB regulated industry.
Detailed knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required for this role.
Background as a technical leader in a process engineering, formulations or technical transfer capacity.
Experience of start-ups and/or new product introductions to pharmaceutical facilities. Must be able to lead & project manage these activities.
Demonstrated project management skills, including the ability to deliver projects on schedule, within budget, and meeting the predefined quality requirements. Previous exposure to supply chain & schedule delivery in a manufacturing environment.
A minimum of 1 year previous experience of supervising a team environment with active participation in proactive improvement programs
Suitable direct supervisory experience or training.
Package:
€55K-€65K based on relevant prior experience
Permanent staff position
Shift rotations over 15 day cycle, (morning, afternoon, nights - 24hr operations)
25% Shift allowances
Comprehensive Medical plan
Defined Benefits Contributory Pension
21 days holidays
Canteen on site
Very active sports & social club
Contact
Sheila McNeice is the consultant managing this position. If you have any queries about this role, you can contact her by e-mail Karen@jobcontax.com or phone +353-91-395625
Click to connect with Karen on LinkedIn
Similar Roles
Biotech / Pharma / Medical Device Jobs in Ireland
Amgen Jobs - Dublin
Genzyme Jobs - Waterford
Jobs in Cork
Jobs in Lime
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical
