Senior Operations Specialist - (Day shift Monday to Friday)
Apply NowCompany: Kurtosys
Location: Dublin, CA 94568
Description:
Job Title
Senior Operations Specialist - (Day shift Monday to Friday)
Requisition
JR000014909 Senior Operations Specialist - (Day shift Monday to Friday) (Open)
Location
Dublin, IRL
Additional Locations
Job Description Summary
The Senior Operations Specialist will play a key role in learning and development and driving change in the organisation.
The Senior Operations Specialist will drive key operational improvements across the business in line with best industry practices.
The Senior Operations Specialist will be directly involved in the manufacture of our products to the highest standards of safety, potency, efficacy and quality. You will work within the guidelines of cGMP to ensure conformance with all regulatory requirements and site SOPs, while assisting in the implementation of process improvements and enhancements. The Senior Operations Specialist will assist in facility and equipment modifications, product demonstration and Validation activities as the need arises. The successful candidate will be required to provide input on equipment installation, start-up, operation and troubleshooting to support introduction of new products into sustaining operations.
The Senior Operations Specialist will support safety and quality events, CAPAs and change controls. The successful candidate will be a person with a strong work ethic, a self-motivated team player with an excellent can-do attitude. She / He will have a strong sense of responsibility, a high emphasis on Quality, Integrity, Discipline and Teamwork.
The role reports to the Manufacturing Operations Lead in the Manufacturing Dept.
Job Description
Essential Functions
Ownership of the Learning and Development Program for CPMF with a focus on developing playbooks as key part of Knowledge Retention
Develop an accelerated competency-based training plan focused on innovation and RFT execution.
Drive the process training for all Operational Specialists to reach 100% of training across all steps
Responsible for execution of all tasks associated with the preparation for and production of Mallinckrodt products in a cGMP environment ensuring full attention to detail and excellent documentation skills.
Assist in maintaining a safe, cGxP compliant work environment at all times.
Responsible for completion of tasks according to SOPs and Production batch records (PBR's)
Participate on project teams both above site and internally to support key business initiatives.
Support introduction of new products into sustaining operations through the execution of Product Demonstration and Validation activities
Contamination Control Champion focusing on implementing improvements in line with current best industry practices and establish a collaborative working relationship with QC Micro and QA Depts
Ownership of the Cleaning Robustness and Validation Program on site
Support Engineering, calibration, and utility equipment maintenance activities - Perform initial troubleshooting of issues identified during start-up and routine operations.
Drafting and updating of area SOPs, WI and batch records.
Drive the training of colleagues in SOPs, process execution and equipment operation.
Provide support to Quality Operations where required.
Drive a culture of Engagement and Continuous Improvement through identifying and implementing opportunities for improvement in process efficiency and compliance.
Provide support for initiation and completion of deviations, CAPAs, and change controls for process systems.
Support the delegation of activities in Operations and development of weekly work schedules.
Support Safety/Gemba walkdowns on the floor
Support site audit readiness program.
Training Champion for Operations team facilitating roll out of classroom and practical courses.
Good Technical knowledge of manufacturing processes and equipment.
Support complex investigations by providing key SME input.
Minimum Requirements
Education / Experience / Skills:
Organizational Relationship/Scope:
The Senior Operations Transformation Specialist is a key frontline role reporting directly to the Manufacturing Operations Lead at College Park Mallinckrodt Pharmaceuticals Manufacturing facility.
Working Conditions:
This will be a day-based role with a flexibility allowance as part of the renumeration package to cover ad-hoc out of office batch scheduling requirements. Due to the nature of this frontline position, on site work is a requirement.
Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
#LI-KD1
Senior Operations Specialist - (Day shift Monday to Friday)
Requisition
JR000014909 Senior Operations Specialist - (Day shift Monday to Friday) (Open)
Location
Dublin, IRL
Additional Locations
Job Description Summary
The Senior Operations Specialist will play a key role in learning and development and driving change in the organisation.
The Senior Operations Specialist will drive key operational improvements across the business in line with best industry practices.
The Senior Operations Specialist will be directly involved in the manufacture of our products to the highest standards of safety, potency, efficacy and quality. You will work within the guidelines of cGMP to ensure conformance with all regulatory requirements and site SOPs, while assisting in the implementation of process improvements and enhancements. The Senior Operations Specialist will assist in facility and equipment modifications, product demonstration and Validation activities as the need arises. The successful candidate will be required to provide input on equipment installation, start-up, operation and troubleshooting to support introduction of new products into sustaining operations.
The Senior Operations Specialist will support safety and quality events, CAPAs and change controls. The successful candidate will be a person with a strong work ethic, a self-motivated team player with an excellent can-do attitude. She / He will have a strong sense of responsibility, a high emphasis on Quality, Integrity, Discipline and Teamwork.
The role reports to the Manufacturing Operations Lead in the Manufacturing Dept.
Job Description
Essential Functions
Ownership of the Learning and Development Program for CPMF with a focus on developing playbooks as key part of Knowledge Retention
Develop an accelerated competency-based training plan focused on innovation and RFT execution.
Drive the process training for all Operational Specialists to reach 100% of training across all steps
Responsible for execution of all tasks associated with the preparation for and production of Mallinckrodt products in a cGMP environment ensuring full attention to detail and excellent documentation skills.
Assist in maintaining a safe, cGxP compliant work environment at all times.
Responsible for completion of tasks according to SOPs and Production batch records (PBR's)
Participate on project teams both above site and internally to support key business initiatives.
Support introduction of new products into sustaining operations through the execution of Product Demonstration and Validation activities
Contamination Control Champion focusing on implementing improvements in line with current best industry practices and establish a collaborative working relationship with QC Micro and QA Depts
Ownership of the Cleaning Robustness and Validation Program on site
Support Engineering, calibration, and utility equipment maintenance activities - Perform initial troubleshooting of issues identified during start-up and routine operations.
Drafting and updating of area SOPs, WI and batch records.
Drive the training of colleagues in SOPs, process execution and equipment operation.
Provide support to Quality Operations where required.
Drive a culture of Engagement and Continuous Improvement through identifying and implementing opportunities for improvement in process efficiency and compliance.
Provide support for initiation and completion of deviations, CAPAs, and change controls for process systems.
Support the delegation of activities in Operations and development of weekly work schedules.
Support Safety/Gemba walkdowns on the floor
Support site audit readiness program.
Training Champion for Operations team facilitating roll out of classroom and practical courses.
Good Technical knowledge of manufacturing processes and equipment.
Support complex investigations by providing key SME input.
Minimum Requirements
Education / Experience / Skills:
- Working knowledge of production operations with a strong focus on attention to detail and compliance to all regulatory standards.
- Demonstrated experience of training personnel effectively.
- Good understanding of industry best practices across contamination control, cleaning validation, learning and development
- An ability to work independently and as part of a team. The individual in this position will be able to organize his/her own work on a routine basis and requires minimal supervision.
- Minimum degree level qualification in a related discipline (Chemistry, Engineering, Biotechnology etc.) plus 5 years relevant experience in a cGMP commercial manufacturing environment.
- Knowledge of GMP utility systems (i.e., WFI, clean steam, pharmaceutical gas systems) is desirable.
- Experience in working in cross functional teams.
- This job description indicates the general nature and level of work expected of the incumbent. It is not designed to cover or contain a comprehensive listing of all activities, duties or responsibilities requires of the incumbent. Incumbents may be asked to perform other duties as required.
- Good interpersonal and communication skills, verbal and written.
- Collaborator with strong levels of engagement with individuals and teams
- Strong influencing skills with the ability to translate a key message with a clear purpose.
- High level of delivery and work completion. A proven track record of delivering on commitments.
- A knowledge of Continuous improvement principles and tools.
Organizational Relationship/Scope:
The Senior Operations Transformation Specialist is a key frontline role reporting directly to the Manufacturing Operations Lead at College Park Mallinckrodt Pharmaceuticals Manufacturing facility.
Working Conditions:
This will be a day-based role with a flexibility allowance as part of the renumeration package to cover ad-hoc out of office batch scheduling requirements. Due to the nature of this frontline position, on site work is a requirement.
Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
#LI-KD1