Title: Senior Specialist, Metrology Lab
Waterford, Munster, IE
Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.
At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.
Job Summary:
The Senior Specialist, Metrology Global Laboratory serve as a subject matter expert for metrology and is responsible for overseeing and drive of global site laboratory equipment implementation, harmonization, and qualification programs. This involves strong collaboration with Analytical site Labs, other functions within our organization (such as D&T, Quality and West´s Data Integrity Program Lead) and external vendors/suppliers. In addition, this is support for all global site laboratories projects.
Essential Duties and Responsibilities:
- Serve as a subject matter expert and point of contact for analytical instrument metrology. Drive equipment harmonization process across global laboratories. SME Support and global alignment of:
- Procurement of new Equipment and Technology
- Annual Installation Qualifications and Calibrations
- Preventative maintenance
- Troubleshooting
- Repairs
- Lab Instrument asset management and life cycle
- Lab Instruments retirement
- Assist with yearly budget preparation and provide reporting for global Lab instrument CAPEX.
- Author, review and approve controlled instrument documents such as investigations, work instructions, and standard operating procedures.
- Create/write/review of equipment and software Qualification or Validation documents such as Master Validation Plan, IQ, OQ, PQ protocols, summary reports and other.
- Collaborate with vendors/suppliers/internal functional groups to ensure equipment needs and process improvements within global site laboratories are communicated, implemented and deliverables timely scheduled.
- Keep current with new technologies, global/regional/ local standards, data integrity, cGMP and other regulations.
- Responsible for project management of new metrology activities at each Analytical site lab. Provide support for tracking, communicate project status and technical and schedule risks to internal stakeholders, participate in realization of implementation of new technology in routine use, including summarizing lessons learned and hands on training for new equipment.
- Performs other duties as assigned based on business needs.
Basic Qualifications:
- Bachelor’s Degree in Laboratory Science or other related field or equivalent education/experience
- Experience: 5-8 years of experience
- Excellent English verbal and written communication skills
- Exceptional organizational skills
Preferred Knowledge, Skills and Abilities:
- Experience in the use, maintenance, and repair on analytical instrumentation
- Knowledge of calibration accuracy testing requirements and metrology
- Understanding of regulatory guidelines such as ISO, USP, DI and GMP
- Experience in a pharmaceutical related field with experience in a laboratory setting
- Demonstrated strong project and people management skills
- Able to be aware and comply with all relevant SOPs as per Company policy as they are related to the position covered by this Job Description. Able to always comply with the company’s safety and quality policy.
Travel Requirements:
- Must be able to travel up to 10% of the time.
Physical and Mental Requirements:
- Physical demand - Sedentary.
- Strong interpersonal skills with the ability to communicate effectively at all levels
- Must be able to express or exchange ideas with other team members.
- Demonstrated ability to set priorities and meet deadlines.
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.