Scientist, P&P

This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week. No Relocation is privded for this oppportunity 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.   Job Summary

In this role you will support the laboratory with data review generated to comply with cGMP and Data Integrity (DI). You will be responsible to ensure raw data and electronic data are reviewed on a timely manner and comply with cGMP, DI and West requirements. You will execute daily SAP review and locking of results along with audit trail reviews. Essential Duties and Responsibilities

Perform analysis using various techniques including established and experimental test methods.  Use instrumentation both qualitatively and quantitatively where appropriate.

Intron/Zwick/UV/or 3D Printing & CAD experience is a plus

Manage projects from protocol to final report.  Train and certify analysts as appropriate.  Develop and validate methods. Keep current with new analytical technology. Possess ability to work independently and as part of a team with self-motivation, adaptability, and a positive attitude. Prepare technical reports based on data from multiple analysts utilizing multiple analytical techniques. Prepare work instructions, SOPs, and qualification documentation. Prepare lab study designs and prepare study plans and protocols. Interact with internal and external clients as needed.  Willingness to learn and apply new analytical techniques. Perform lab investigations, OOS, and OOT as required. Serve as a role model for positive leadership. Meet individual and departmental goals as required.

Apply required cGMP regulations and internal QA procedures Adhere to established laboratory safety procedures.

Other responsibilities as assigned including but limit to performing clean room testing. Additional Responsibilities

BS in biomedical engineering, chemical engineering, mechanical engineering, or related technical degre Work Experience

Minimum 3 years 3 -5 years of professional experience in a lab environment required and Experience in pharmaceutical/medical device field and implementing laboratory training programs required and Preferred Knowledge, Skills and Abilities

cGMP ISO and USP/EP compendia Strong oral and written communication skills and attention to detail required Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description License and Certifications

None: No travel required Physical Requirements

Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Additional Requirements

Job-related activities that require a physical activity such as standing in