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.
Summary:
In this role, you will assist and support the validation team by sampling, reviewing, and analyzing metrology data and providing feedback to the validation team on a regular basis. Assist in Batch Documentation release, scrap reporting and sign off. Provide support and assistance in creating and drafting validation protocols and reports where required. Reports to and provides support to the Process Engineer during the validation execution.
Essential Duties and Responsibilities:
Plan, develop, organize, write, edit and review operational procedures and validation documentation.
Analyze documents to maintain continuity of style of content and utilize good documentation practices.
Study products and processes and consult subject matter experts to gather data.
Collaborate with, and when necessary, manage site resources to ensure timely and successful validation of new equipment and processes.
Complete documentation for OQ and PQ runs, including measurement and inspection, and assist the Process Engineer in the setup and execution of all validation activities.
Utilize software to route and control documents for revisions and approval of technical literature.
Assist in preparing IQ, OQ and PQ protocols and reports.
Communicate appropriately with customers (internal and external) to determine documentation requirements.
Partner with Metrology department to provide feedback on results and provide updates to validation team.
Collaborate with, and when necessary, manage site resources to ensure timely and successful validation of new equipment and processes.
Develop documentation across multiple projects and teams simultaneously.
Support and contribute in Lean Sigma programs and activities towards delivery of the set target
Other duties as assigned.
Basic Qualifications:
Bachelor's Degree related to technical field or equivalent experience preferred
High School Diploma GED or equivalent experience required
Preferred Knowledge, Skills and Abilities:
1 year experience in manufacturing environment and understanding of good manufacturing practices.
3 years' experience in manufacturing environment and understanding of good manufacturing and regulatory compliance within an FDA certified facility
Experience of using statistical techniques for Data Analysis (preferably using Minitab).
KSAs
Knowledge and experience with FDA and ISO Quality Systems to include SPC and calibrations systems.
Proficiency with PC and Microsoft Office; Knowledge of QMS Master Control, MeasureLink and other Quality systems is preferred.
Experience with ISO 9000 standards and GMP's
Strong attention to detail; Strong problem identification/analysis and solving skills with hands-on approach.
Excellent verbal and written communication skills; Maintain an organized and clean quality Lab.
Ability to multi-task and prioritize in a fast-paced environment; Ability to interface with all personnel levels.
Motivated self-starter with ability to work independently on multiple assignments in a team environment.
Travel Requirements:
Estimated Amount
10%: Up to 26 business days per year
Physical Requirements:
Exerting up to 20lbs/9kg of force frequently, and/or negligible amount of force frequently constantly to move objects. If the use of arm and/or leg control requires exertion of force greater than that of sedentary work and if the worker sits most of the time, the job is considered light work.
Additional Requirements
Ability to work on location and operate equipment or gown as needed
While performing the duties of this job, the associate frequently is required to sit, walk, stand, balance, stoop, kneel, or crouch to support production needs. The associate may lift and/or move up to 25 pounds and occasionally lift and/or move more than 55 pounds.
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 and/or a pre-employment drug screening.
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 disability or special need that requires accommodation, please send an email to [email protected].
