Sr Spec, Validation, Global Eng Full-time Job
9 months ago - Medical & Healthcare - DublinJob Details
Requisition ID: 63370
Date: Oct 6, 2023
Location:
Dublin, Leinster, IE
Department: Engineering
Description:
Fixed Term Contract: 12 months
At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?
There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.
We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.
Job Summary:
In this role, you will support NPI projects with key focus around customer specification, Validation Master Plan, protocols, and reports. Provide the company with the technical and Validation resource to manage the Validation deliverables on selected NPI projects and will coordinate the necessary activities for ensuring the timely closure of Validation activities on projects.
Essential Duties and Responsibilities:
Support the validation effort for all Strategic Projects on site.
Chair, schedule, and minute validation meetings and participate in meetings when required.
Prepare, review and or approval of qualification and/or validation documentation (VMPs, specifications, protocols, reports etc.) in relation to instrument, equipment, facilities, utilities, automated systems, manufacturing processes and cleaning processes including FAT, SAT, IQ, OQ, PQ phases in conjunction with program Quality representation.
Generating, communicating, and updating Validation document tracker.
Manage the archiving and filing of validation documentation associated with the project, including the management of same on MasterControl.
Lead equipment process and / or Design FMEAs.
Leading the review and disposition of all attribute and variable data for the program against customer specification / drawing e.g. Analysing and reporting of key measures e.g. Ppk's, Cpk's, FOT/FAT visual inspections.
Drive solutions, in conjunction with the appropriate department, to ensure customer related validation problems are communicated and corrective actions are in place and closed in a timely manner.
Lead data/presentations and attend review meetings with the customer.
Implement best practices principles into West QMS as applicable.
Support internal and supplier audits.
Trending and tracking of Validation data to drive improvements e.g., Sampling data, project protocols and reports.
Other duties as assigned.
Basic Qualifications:
Third level qualification, at a minimum to degree level, in Engineering/Quality or Science
Must have a minimum of 5 years post graduate experience of working in a high-volume manufacturing environment ideally in the Medical Device / Pharmaceutical sector.
A thorough working knowledge of quality systems such as ISO 13485 / 21 CFR Part 820 is essential
Must have an in-depth knowledge of validations in a Medical Device environment.
Preferred Knowledge, Skills and Abilities:
An excellent understanding of plastic process manufacturing
Good understanding of computer system validation
Must have a thorough understanding of statistics, SPC, and ideally the use of Minitab.
Auditing experience to the requirements of ISO 13485 / 21 CFR Part 820 is preferred.
Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
Support and contribute in Lean Sigma programs and activities towards delivery of the set target
Able to comply with the company’s safety policy at all times.
Able to comply with the company’s quality policy at all times.
Travel Requirements:
Must be able to travel up to 20 % of the time.
Physical and Mental Requirements:
Physical:
Sedentary- exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to life, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
Mental:
Demonstrated ability to lead, influence and train others.
Must be able to work in a fast-paced environment.
Must be able to organize and prioritize tasks; must be detail orientated and self-motivated.
Must have excellent communication skills both oral and written.
Must be able to prioritize and organize tasks appropriately.
Delegation of Duties:
When absent from the site duties and responsibilities will be delegated to the following designates:
Program Validation Manager
West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com. Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.
Date: Oct 6, 2023
Location:
Dublin, Leinster, IE
Department: Engineering
Description:
Fixed Term Contract: 12 months
At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?
There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.
We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.
Job Summary:
In this role, you will support NPI projects with key focus around customer specification, Validation Master Plan, protocols, and reports. Provide the company with the technical and Validation resource to manage the Validation deliverables on selected NPI projects and will coordinate the necessary activities for ensuring the timely closure of Validation activities on projects.
Essential Duties and Responsibilities:
Support the validation effort for all Strategic Projects on site.
Chair, schedule, and minute validation meetings and participate in meetings when required.
Prepare, review and or approval of qualification and/or validation documentation (VMPs, specifications, protocols, reports etc.) in relation to instrument, equipment, facilities, utilities, automated systems, manufacturing processes and cleaning processes including FAT, SAT, IQ, OQ, PQ phases in conjunction with program Quality representation.
Generating, communicating, and updating Validation document tracker.
Manage the archiving and filing of validation documentation associated with the project, including the management of same on MasterControl.
Lead equipment process and / or Design FMEAs.
Leading the review and disposition of all attribute and variable data for the program against customer specification / drawing e.g. Analysing and reporting of key measures e.g. Ppk's, Cpk's, FOT/FAT visual inspections.
Drive solutions, in conjunction with the appropriate department, to ensure customer related validation problems are communicated and corrective actions are in place and closed in a timely manner.
Lead data/presentations and attend review meetings with the customer.
Implement best practices principles into West QMS as applicable.
Support internal and supplier audits.
Trending and tracking of Validation data to drive improvements e.g., Sampling data, project protocols and reports.
Other duties as assigned.
Basic Qualifications:
Third level qualification, at a minimum to degree level, in Engineering/Quality or Science
Must have a minimum of 5 years post graduate experience of working in a high-volume manufacturing environment ideally in the Medical Device / Pharmaceutical sector.
A thorough working knowledge of quality systems such as ISO 13485 / 21 CFR Part 820 is essential
Must have an in-depth knowledge of validations in a Medical Device environment.
Preferred Knowledge, Skills and Abilities:
An excellent understanding of plastic process manufacturing
Good understanding of computer system validation
Must have a thorough understanding of statistics, SPC, and ideally the use of Minitab.
Auditing experience to the requirements of ISO 13485 / 21 CFR Part 820 is preferred.
Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
Support and contribute in Lean Sigma programs and activities towards delivery of the set target
Able to comply with the company’s safety policy at all times.
Able to comply with the company’s quality policy at all times.
Travel Requirements:
Must be able to travel up to 20 % of the time.
Physical and Mental Requirements:
Physical:
Sedentary- exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to life, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
Mental:
Demonstrated ability to lead, influence and train others.
Must be able to work in a fast-paced environment.
Must be able to organize and prioritize tasks; must be detail orientated and self-motivated.
Must have excellent communication skills both oral and written.
Must be able to prioritize and organize tasks appropriately.
Delegation of Duties:
When absent from the site duties and responsibilities will be delegated to the following designates:
Program Validation Manager
West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com. Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.
