Process technical lead responsible for process development and technical troubleshooting of the biologics/medical device process & associated equipment at the Limerick facility.
This position is also responsible for technical input to plan, design, develop, and validate the manufacturing processes for new products/processes working with cross-functional teams including:
R&D, Quality Engineering, Clinical Teams, Analytical Labs, Procurement, Manufacturing, and Environmental/Safety.
This person will be the process SME once the operation is manufacturing saleable product.
Main duties and responsibilities:
Lead the process transfer from host Manufacturing operation and ensure seamless start-up at the receiving (Limerick) site.
Serves as Technical SME on both equipment and process for assigned key process technologies
Executes process development/transfer activities utilizing DOE and other relevant statistical process engineering methodologies resulting in sound scientific reports.
Will collaborate significantly with internal/external functions and suppliers to finalize product design, material and process selection.
Assist in transfer of processes from Research and Development/FOD to manufacturing
Develop, design, construct, validate processes using new or existing technologies for a classified environment.
Early management of the operational, environmental, safety and technical aspects of the process to ensure smooth product commercialization.
Provide routine technical support for assigned process and packaging activities.
Ensure and lead the generation of lifecycle documentation for process equipment and associated systems.(URS, FDS, DDS, FAT, SAT, IQ/OQ, Risk Assessments, etc)
Leading process change control and validation.
Development & Maintenance of process data base.
Perform data trending on product performance for evaluation process control and to aid in solving product and process problems.
Leading product and production failure investigations, implementing corrective actions, and preparing sound scientific reports.
Review line metrics and provide technical solutions to increase operational efficiency.
Support Engineering functions, such as Factory Acceptance Testing, Commissioning, Qualification, etc. applying good project management and Engineering principles
Generation of data and reports to support Annual Product Reviews and Regulatory submissions.
Technical input to Batch Records, Procedures and Work Instructions
Provide process and equipment related training as required
Working assigned shift patterns to meet business needs and Operations schedule
Follows cGMP guidelines, safety procedures, and SOPs at all times.
Demonstrate Credo value of integrity
Key Skills and Competencies required:
Capble working in a highly regulated GMP Cleanroom environment.
Ability to project manage a multi-functional technical teams
Excellent Mechanical/Technical aptitude.
Strong organizational/administrative skills
Experience in design control for biologics/devices
High proficiency in using statistical risk analysis tools, process capability analysis, technical troubleshooting, i.e. 6-Sigma/Kepner-Tregoe or similar problem solving/decision making methodology.
Experience of working in Grade C or higher classified manufacturing environments.
Effective communication and presentation skills in one-on-one and group situations.
Self-directed and self-motivated.
Excellent interpersonal skills.
Innovative.
Excellent problem solving skills.
Excellent analytical skils.
Strong attention to detail.
Strongly results and performance driven.
Adaptable and flexible.
Requirements:
Essential
Bachelor’s degree from an accredited college or university in either Biotechnology or Engineering.
5+ Years post educational process engineering experience with working in a regulated environment preferably within a Pharma/Biotech facility.
3+ yrs experience in automated manufacturing equipment 1+ years experience working on Grade C or higher classified manufacturing environment
Demonstrated experience in new product process design and development for new products / processes with multiple factors, responses and interactions.
Proven Project Management experience as a Project Engineer
Desirable
Experience of Biologics Production & Regulatory Requirements
Experience of Aseptic Manufacturing processes
Experience of working on combination product manufacture.
Experience of ERP, MES, LIM’s and/or other business systems.
Package:
Permanent Full time position
Competitive salary
Benefits - Pension, healthcare etc
Performance bonus schemes
Contact:
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720
Click to connect with Karen on LinkedIn
Similar Jobs
Biotech / Pharma / Medical Device Jobs in Ireland
Amgen Jobs - Dublin
Genzyme Jobs - Waterford
JJob Description
Process technical lead responsible for process development and technical troubleshooting of the biologics/medical device process & associated equipment at the Limerick facility.
This position is also responsible for technical input to plan, design, develop, and validate the manufacturing processes for new products/processes working with cross-functional teams including:
R&D, Quality Engineering, Clinical Teams, Analytical Labs, Procurement, Manufacturing, and Environmental/Safety.
This person will be the process SME once the operation is manufacturing saleable product.
Main duties and responsibilities:
Lead the process transfer from host Manufacturing operation and ensure seamless start-up at the receiving (Limerick) site.
Serves as Technical SME on both equipment and process for assigned key process technologies
Executes process development/transfer activities utilizing DOE and other relevant statistical process engineering methodologies resulting in sound scientific reports.
Will collaborate significantly with internal/external functions and suppliers to finalize product design, material and process selection.
Assist in transfer of processes from Research and Development/FOD to manufacturing
Develop, design, construct, validate processes using new or existing technologies for a classified environment.
Early management of the operational, environmental, safety and technical aspects of the process to ensure smooth product commercialization.
Provide routine technical support for assigned process and packaging activities.
Ensure and lead the generation of lifecycle documentation for process equipment and associated systems.(URS, FDS, DDS, FAT, SAT, IQ/OQ, Risk Assessments, etc)
Leading process change control and validation.
Development & Maintenance of process data base.
Perform data trending on product performance for evaluation process control and to aid in solving product and process problems.
Leading product and production failure investigations, implementing corrective actions, and preparing sound scientific reports.
Review line metrics and provide technical solutions to increase operational efficiency.
Support Engineering functions, such as Factory Acceptance Testing, Commissioning, Qualification, etc. applying good project management and Engineering principles
Generation of data and reports to support Annual Product Reviews and Regulatory submissions.
Technical input to Batch Records, Procedures and Work Instructions
Provide process and equipment related training as required
Working assigned shift patterns to meet business needs and Operations schedule
Follows cGMP guidelines, safety procedures, and SOPs at all times.
Demonstrate Credo value of integrity
Key Skills and Competencies required:
Capble working in a highly regulated GMP Cleanroom environment.
Ability to project manage a multi-functional technical teams
Excellent Mechanical/Technical aptitude.
Strong organizational/administrative skills
Experience in design control for biologics/devices
High proficiency in using statistical risk analysis tools, process capability analysis, technical troubleshooting, i.e. 6-Sigma/Kepner-Tregoe or similar problem solving/decision making methodology.
Experience of working in Grade C or higher classified manufacturing environments.
Effective communication and presentation skills in one-on-one and group situations.
Self-directed and self-motivated.
Excellent interpersonal skills.
Innovative.
Excellent problem solving skills.
Excellent analytical skils.
Strong attention to detail.
Strongly results and performance driven.
Adaptable and flexible.
Requirements:
Essential
Bachelor’s degree from an accredited college or university in either Biotechnology or Engineering.
5+ Years post educational process engineering experience with working in a regulated environment preferably within a Pharma/Biotech facility.
3+ yrs experience in automated manufacturing equipment 1+ years experience working on Grade C or higher classified manufacturing environment
Demonstrated experience in new product process design and development for new products / processes with multiple factors, responses and interactions.
Proven Project Management experience as a Project Engineer
Desirable
Experience of Biologics Production & Regulatory Requirements
Experience of Aseptic Manufacturing processes
Experience of working on combination product manufacture.
Experience of ERP, MES, LIM’s and/or other business systems.
Package:
Permanent Full time position
Competitive salary
Benefits - Pension, healthcare etc
Performance bonus schemes
Contact:
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720
Click to connect with Karen on LinkedIn
Similar Jobs
Biotech / Pharma / Medical Device Jobs in Ireland
Amgen Jobs - Dublin
Genzyme Jobs - Waterford
J
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical
