Title:  Spec, Tech Invest, Ops, Dublin

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:

Reporting to the Value Stream Lead within Operations this role ensures effective problem solving and closure of non-conformances within compliance to the Quality Management System.

Essential Duties and Responsibilities:

• Objectively facilitating cross functional teams to the correct identification of the root cause and identifying robust corrective and preventive actions to avoid reoccurring problems and investigations.
• Responsible for completion of investigations in compliance with Quality standards
• Utilizing lean tools and problem-solving tools while improving the problem-solving process, for the enhancement of site processes and performance
• Responsible for gathering, trending and analysing data to accurately clarify problems and identify continues improvements across the business
• Ensures that investigations comply with the Quality standards implemented in the business
• Responsible for clearly documenting investigations within the required timeframes to meet business and compliance needs
• Participates in regulatory inspections to present and defend investigations when required.
• Ensuring the timely and effective closure of day-to-day quality issues.
• Proactively improve processes to deliver competitive advantage for both the Business and customer
• Coach and drive a culture of compliance and continuous improvement.
• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance to all site Environmental, Health and Safety requirements, training, and regulations.
• Compliance to all local site company policies, procedures, and corporate policies.
• Perform additional duties at the request of the direct supervisor

Basic Qualifications: 

• Must have a third level qualification in Engineering/Quality/Science.
• Must have 3+ years’ work experience in the Medical, Pharmaceutical, or high-volume regulated manufacturing environment

Preferred Knowledge, Skills and Abilities:

• A working knowledge of quality systems such as ISO 13485/21 CFR Part 820 and EU GMP is essential.
• Ideally have a very good knowledge of Injection Moulding (standard process and Multi component), Processing, Ancillary equipment, and automation systems.
• Ideally have excellent technical writing skills.
• Must have effective problem-solving skills and working knowledge of root cause analysis tools such as 8D and A3
• Must have a working knowledge of statistics and Data analytics, SPC, and ideally the use of statistical packages.
• Must have excellent communication skills both oral and written.
• Must have knowledge in computer systems; integrated manufacturing systems; word processing and spread sheets.
• Must have excellent written and verbal communication skills as well as the ability to accurately document work performed.
• Must be able to deal with all levels of employees and work across various departments

Travel Requirements:

• Must be able to travel up to 5% of the time or when required

Physical & Mental Requirements:

• Must be able to work in a fast-paced environment.
• Must be able to organize and prioritize tasks; be detail orientated and self-motivated.
• An ability to collaborate across functional teams and work effectively in a matrixed team environment.
• Must be able to work independently on own projects while working concurrently with all departments.
• Must be able to multi-task, work under time constraints, problem solve, and prioritize.
• Must also be able to maintain confidentiality and resolve conflicts.
• Ability to make independent and sound judgments.

Competencies/Authorities

• N/A

Delegation of Duties:

• When absent from the site duties and responsibilities will be delegated to the following designates

Value Stream lead- Operations

Job Summary:

Reporting to the Value Stream Lead within Operations this role ensures effective problem solving and closure of non-conformances within compliance to the Quality Management System.

Essential Duties and Responsibilities:

• Objectively facilitating cross functional teams to the correct identification of the root cause and identifying robust corrective and preventive actions to avoid reoccurring problems and investigations.
• Responsible for completion of investigations in compliance with Quality standards
• Utilizing lean tools and problem-solving tools while improving the problem-solving process, for the enhancement of site processes and performance
• Responsible for gathering, trending and analysing data to accurately clarify problems and identify continues improvements across the business
• Ensures that investigations comply with the Quality standards implemented in the business
• Responsible for clearly documenting investigations within the required timeframes to meet business and compliance needs
• Participates in regulatory inspections to present and defend investigations when required.
• Ensuring the timely and effective closure of day-to-day quality issues.
• Proactively improve processes to deliver competitive advantage for both the Business and customer
• Coach and drive a culture of compliance and continuous improvement.
• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance to all site Environmental, Health and Safety requirements, training, and regulations.
• Compliance to all local site company policies, procedures, and corporate policies.
• Perform additional duties at the request of the direct supervisor

Basic Qualifications: 

• Must have a third level qualification in Engineering/Quality/Science.
• Must have 3+ years’ work experience in the Medical, Pharmaceutical, or high-volume regulated manufacturing environment

Preferred Knowledge, Skills and Abilities:

• A working knowledge of quality systems such as ISO 13485/21 CFR Part 820 and EU GMP is essential.
• Ideally have a very good knowledge of Injection Moulding (standard process and Multi component), Processing, Ancillary equipment, and automation systems.
• Ideally have excellent technical writing skills.
• Must have effective problem-solving skills and working knowledge of root cause analysis tools such as 8D and A3
• Must have a working knowledge of statistics and Data analytics, SPC, and ideally the use of statistical packages.
• Must have excellent communication skills both oral and written.
• Must have knowledge in computer systems; integrated manufacturing systems; word processing and spread sheets.
• Must have excellent written and verbal communication skills as well as the ability to accurately document work performed.
• Must be able to deal with all levels of employees and work across various departments

Travel Requirements:

• Must be able to travel up to 5% of the time or when required

Physical & Mental Requirements:

• Must be able to work in a fast-paced environment.
• Must be able to organize and prioritize tasks; be detail orientated and self-motivated.
• An ability to collaborate across functional teams and work effectively in a matrixed team environment.
• Must be able to work independently on own projects while working concurrently with all departments.
• Must be able to multi-task, work under time constraints, problem solve, and prioritize.
• Must also be able to maintain confidentiality and resolve conflicts.
• Ability to make independent and sound judgments.

Competencies/Authorities

• N/A

Delegation of Duties:

• When absent from the site duties and responsibilities will be delegated to the following designates

Value Stream lead- Operations

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.