To lead and project manage Mfg Equipment/qualifications and co-ordinate the start-up of these ready for handover to operations. It is also envisaged that this person will be the onsite subject matter expert in all packaging requirements, equipment, packaging specs and materials used for the primary, secondary and tertiary of the finished product.This person is will be responsible for the day to day engineering activities associated with this equipment and be the packaging SME once the operation is manufacturing saleable product.
Main duties and responsibilities:
Responsible for managing the development, testing, installation and qualification of Mfg
Equipment/Packaging systems and processes with handover to operations in a highly regulated combination type biologics/medical device facility.
Lead the packaging technology transfer from host Mfg operation and ensure seamless start-up of all packaging (Primary, Secondary and Tertiary)
Co-ordinate activities with all stakeholders through commercialization
Lead the implementation activities for commercialization of Mfg equipment and packaging processes, applying good project management and Engineering principles, installation, start-up and handover at pre-determined guaranteed performance. All the equipment and packaging processes included in his/her area of responsibility.
Ensure alignment of Mfg equipment and packaging deliverables with the requirements of operations.
Ensure and lead the generation of lifecycle documentation for equipment under their ownership (URS, FDS, DDS, FAT, SAT, IQ/OQ, Risk Assessments, etc)
Early management of the operational, environmental, safety and technical aspects of the equipment/packaging processes to ensure smooth product commercialization.
Review line metrics and provide engineering solutions to increase operational efficiency and equipment effectiveness during commercial operation.
Develop themselves as an expert in their area of responsibility for a long-term support of the operation in commercial manufacture.
Lead in implementing continous improvement projects for their respective areas of responsibility up to and during commercial manufacture of the product.
Leading failure investigations and implementing corrective and preventative actions for their respective areas of responsibility.
Identifying of spare parts lists and inctruments requiring calibration for equipment under your responsibility.
Assist in necessary training of the personnel.
Management of as-built drawings, maintenance plans and training of operators.
Follows cGMP guidelines, safety procedures, and SOPs at all times.
Key Skills and Competencies required:
Experience working is a highly regulated GMP environment is very important.
Knowledge of Aseptic Manufacturing process is desirable but not essential.
Experience in automated manufacturing equipment.
Significant packaging experience (raw materials, packaging processes, packaging equipment).
Proven Project Management experience as a Project Engineer
Ability to manage a multi-functional team
Good organizational/administrative skills
Competent design knowledge
Effective communication and presentation skills in one-on-one and group situations.
High proficiency in using Microsoft Word, Excel, PowerPoint and MS Project
AutoCAD knowledge is desirable
Ability to understand manufacturing processes, and to identify improvements.
Skills to prepare written policies, procedures and reports.
Ability to handle various responsibilities simultaneously.
Demonstrated experience in new product process design and development for new products / processes with multiple factors, responses and interactions.
Self-directed and self-motivated.
Requirements:
Bachelor’s degree from an accredited college or university, preferably in Mechanical, Manufacturing Engineering or equivalent disciplines.
3 Years minimum post educational experience with working in a regulated environment preferably within a Pharma/Biotech facility.
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
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Job Description
To lead and project manage Mfg Equipment/qualifications and co-ordinate the start-up of these ready for handover to operations. It is also envisaged that this person will be the onsite subject matter expert in all packaging requirements, equipment, packaging specs and materials used for the primary, secondary and tertiary of the finished product.This person is will be responsible for the day to day engineering activities associated with this equipment and be the packaging SME once the operation is manufacturing saleable product.
Main duties and responsibilities:
Responsible for managing the development, testing, installation and qualification of Mfg
Equipment/Packaging systems and processes with handover to operations in a highly regulated combination type biologics/medical device facility.
Lead the packaging technology transfer from host Mfg operation and ensure seamless start-up of all packaging (Primary, Secondary and Tertiary)
Co-ordinate activities with all stakeholders through commercialization
Lead the implementation activities for commercialization of Mfg equipment and packaging processes, applying good project management and Engineering principles, installation, start-up and handover at pre-determined guaranteed performance. All the equipment and packaging processes included in his/her area of responsibility.
Ensure alignment of Mfg equipment and packaging deliverables with the requirements of operations.
Ensure and lead the generation of lifecycle documentation for equipment under their ownership (URS, FDS, DDS, FAT, SAT, IQ/OQ, Risk Assessments, etc)
Early management of the operational, environmental, safety and technical aspects of the equipment/packaging processes to ensure smooth product commercialization.
Review line metrics and provide engineering solutions to increase operational efficiency and equipment effectiveness during commercial operation.
Develop themselves as an expert in their area of responsibility for a long-term support of the operation in commercial manufacture.
Lead in implementing continous improvement projects for their respective areas of responsibility up to and during commercial manufacture of the product.
Leading failure investigations and implementing corrective and preventative actions for their respective areas of responsibility.
Identifying of spare parts lists and inctruments requiring calibration for equipment under your responsibility.
Assist in necessary training of the personnel.
Management of as-built drawings, maintenance plans and training of operators.
Follows cGMP guidelines, safety procedures, and SOPs at all times.
Key Skills and Competencies required:
Experience working is a highly regulated GMP environment is very important.
Knowledge of Aseptic Manufacturing process is desirable but not essential.
Experience in automated manufacturing equipment.
Significant packaging experience (raw materials, packaging processes, packaging equipment).
Proven Project Management experience as a Project Engineer
Ability to manage a multi-functional team
Good organizational/administrative skills
Competent design knowledge
Effective communication and presentation skills in one-on-one and group situations.
High proficiency in using Microsoft Word, Excel, PowerPoint and MS Project
AutoCAD knowledge is desirable
Ability to understand manufacturing processes, and to identify improvements.
Skills to prepare written policies, procedures and reports.
Ability to handle various responsibilities simultaneously.
Demonstrated experience in new product process design and development for new products / processes with multiple factors, responses and interactions.
Self-directed and self-motivated.
Requirements:
Bachelor’s degree from an accredited college or university, preferably in Mechanical, Manufacturing Engineering or equivalent disciplines.
3 Years minimum post educational experience with working in a regulated environment preferably within a Pharma/Biotech facility.
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
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical
