Title:  Production Operator, 100% Inspection FTC

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.  

Fixed Term Contract: 12 months (maternity cover)
Shift Pattern: 3 shift cycle (nights/evenings/days)

Job Summary:

Reporting to the department lead this role is responsible for the production of product that meet or exceed pre-determined specifications. Responsible for manufacture, inspection, packaging, labelling and completion of documentation necessary to provide quality, production and traceability records in accordance with Quality Systems and Environmental Management Systems.

Essential Duties and Responsibilities:

• Manage production flow and output, by carrying out a range of functions including tracking product at each stage of the process, proper labelling and inventory management using Kanbans and automated MES and Plc based systems, to ensure optimum equipment uptime and target outputs.
• Equipment includes, but not limited to - washers, autoclaves, envision, envision tooling, inner pack, outer pack-staging/ material handling, mixing-weighing, drop mill, feed mill, calendar, winder, rotocure and slitter machines, 100% inspection.
• Adhere to standard operating instructions for proper PPE and gowning for entry to production, quality, labs and clean room areas.
• Prepare, set-up and clean machines as per requirements. Adhering to housekeeping and materials management policies in all production areas while focusing on continuous process improvement using Lean Principles.
• Clean room cleaning.
• Gather, record and label samples for testing by QA & Lab departments. Ensuring correct documentation is available and or provided. 
• Carry out product testing and records results as required. 
• Maintain process equipment, assisting & completing preventative maintenance and equipment troubleshooting and repairs where qualified to perform tasks.
• Participate effectively in writing/revising/ rolling out accurate operational procedures, training materials for various systems; ensure all work is carried out in line with same.
• Support continuous improvement by active participation in investigations and investigation reports, execution/development of change control, and contribution to Kaizen events and projects as appropriate. Perform root cause analysis, using standard tools and methods, to resolve system issues e.g. FMEA, A3/A4
• Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
• Understand the specific responsibilities of all departments as they relate to one’s own department, understanding the business processes one’s department supports.
• Work collaboratively to drive a safe and compliant culture. Compliance to all local site Environmental, Health and Safety regulations.
• Adheres to methods/procedures and policies to meet the requirements of Quality Systems and Environmental Management Systems.
• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance to all local site Environmental, Health and Safety regulations.
• Compliance to all local site company policies, procedures and corporate policies.
• Other duties as assigned.

Basic Qualifications: 

• Apprenticeship, Certificate or Diploma preferred; ideally in a mechanical, manufacturing related discipline.
• Minimum Education: Leaving Certificate

Preferred Knowledge, Skills and Abilities:

• Ideal candidates would typically have 3+years prior work experience in the Bio Pharmaceutical /Pharmaceutical or Medical Device Industries, or in another GMP setting.
• Knowledge of Good Manufacturing Practises (cGMP) requirements would be an advantage.
• Shift  work (2/3/4 shift) 
• Proficiency in Microsoft Office and job related computer applications.
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
• Must be able to read and interpret documents such as safety rules, operating and maintenance instructions, procedure manuals and process specification, and ensure that all associated paperwork is completed accurately.
• Must be willing to work in a controlled cleanroom environment, which involves the wearing of a gown, cap and relevant personal protective equipment. 
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description.

Competencies

• Self-motivated
• Flexible approach
• Effective time management and multi-tasking skills
• Excellent attention to detail
• Trouble shooting skills
• Goal/results orientated
• Good verbal reasoning, numerate ability
• Excellent mechanical aptitude
• Strong communication skills, both written and oral.
• Proven ability to work in a team environment
• Strong organisational skills.

Travel Requirements:

• Must be able to travel up to 10% of the time.

West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening.