This is an onsite position requiring the team member to be onsite 5 days a week
No relocation is provided for this opportunity
Who We Are:
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.
What We Offer
Generous Paid Time Off (PTO):
Flexible vacation, personal, and holiday leave ensures employees can maintain a healthy work-life balance and recharge effectively. Continuous Learning & Development: Opportunities for professional growth through training programs, tuition assistance, leadership development, and skill-certification initiatives. Inclusive & Collaborative Culture: A global workforce that values diversity, equity, and inclusion—where all voices are heard and respected in a supportive environment.
Job Summary
In this role, you will be responsible for site laboratory equipment qualification supporting the Senior Metrology Specialist with the lab equipment qualification program. This involves serving as subject matter expert for equipment and associated software, including implementation of new technologies, managing projects and providing technical assistance as required.
This role involves collaboration with laboratory management, vendors, quality, D&T, Global Metrology personnel and West's Data Integrity Program lead. Essential duties are outlined below including acting as metrology expert for computer system validation in line with West Global Procedures. The role will involve provision of training and guidance to analysts for related testing equipment.
Essential Duties and Responsibilities
* Metrology activities related to equipment operation, calibration, qualification, and functionality in a GMP environment.
* Ensure GMP status and functionality of equipment in accordance with 21CFR11/Annex 11 for Data Integrity compliance
* Introduction of new laboratory equipment and software as required in line with change control procedures
* Perform equipment qualification activities (including CSV) as required according to global procedures and requirements associated with the implementation of new computer-based laboratory equipment or upgrades of existing systems as required.
* Establish work instructions and training modules for equipment and provide training to the laboratory team.
* Support Senior Metrology Specialist with coordination of equipment manufacturer/distributor for timely resolution and or commissioning external service providers with support from D&T as required.
* Control & maintain all required calibration standards, gauges, materials used for equipment checks in the laboratory.
* Collaborate with D&T functions in terms of maintaining and administrating computerized systems for laboratory equipment.
* Liaise with global lab projects, Global Labs Metrology Team and principal specialists/SME's and from other labs on equipment and metrology related projects/issues or concerns.
* Actively participate and contribute to global lab equipment role out projects and Global Metrology Team. This may involve supporting the lab as pilot site for initial equipment installation and qualification.
* Support lab instrument asset management and life cycle. Support projects such as Method
* Transfers as sending site or receiving site as appropriate, Verifications, Validations and Equipment Qualifications.
* Create and maintain control forms, SOIs, and general lab documentation.
* Support laboratory investigations as equipment SME as necessary
* Support Lab Management and respond to internal, corporate and customer audits
* Support audit findings, customer queries related to lab equipment
* Lead and participate in problem solving teams for investigations (OOS's) and resolution of problems.
* Support continuous improvement initiatives.
* Maintain cGMP and ISO compliance.
* Develop a higher level of knowledge and skill with current and new analytical technology techniques
* 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 and contribution to Improvement of Safety in the Laboratory.
* Compliance to all local site company policies, procedures and corporate policies.
* Perform new and existing laboratory equipment qualifications (including periodic equipment re-qualifications), and periodic calibration and (preventative) maintenance with external service providers with support from D&T when required.
* Report all non-conformances and equipment failures to the laboratory manager. On call for any equipment related issues in the laboratory.
* Execute any other duties as assigned by the laboratory manager or senior metrology specialist.
Education
* BS in Physics or Engineering related technical degree.
Preferred Knowledge, Skills and Abilities
* 3-5 Years of experience in a GMP Laboratory/environment
* Experience in a cGMP
* Experience in Metrology and lab equipment
* Experience with software applications
* Strong competence in IT
* Good verbal and written communication skills
* Excellent interpersonal skills with the ability to work with all levels within the organization.
* Team player
* Structured way of working & strong organisational skills
* Ability to interact with suppliers, customers and external contractors.
* Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
* Support and contribute to Lean Sigma programs and activities towards delivery of the set target #LI-NJ1 #LI-ONsite
Travel Requirements
5%: Up to 13 business days per year
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 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.