Lab Engineer/Scientist 2

West Pharmaceutical Services•Uwchlan Township, PA

23h•Onsite

About The Position

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 SummaryIn 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.

Requirements

Associate's Degree in Microbiology, Science, or a related discipline required
3+ years of professional experience in a lab environment required
Experience in pharmaceutical/medical device field and implementing laboratory training programs required
Ability to work independently, with minimal guidance and an attention to detail
Ability to adhere to all relevant SOPs, as per Company policy, as they are related to the position covered by this Job Description
Ability to take initiative, to work efficiently to meet deadlines, and to work in a team environment are essential. Able to work independently and remain self-motivated with minimal direct supervision
Well experienced in a cGMP environment.
Technical understanding
Excellent verbal and written communication skills Good verbal and written communication skills
Strong analytical and problem solving skills. Superior verbal/written skills. Good punctuation, spelling, grammar and attention to detail.
Able to comply with the company’s quality policy at all times.
Job-related activities that require a physical activity such as standing in laboratory environment
Use hands to finger, handle, feel or operate objects, tools or controls and reach with hands and arms.
Job-related activities that require a mental skill or ability such as communication, quick decision making, interpreting data, reading or writing, public speaking, etc. (e.g., Must be able to express or exchange ideas with employees; Must be able to understand direction and adhere to established procedures)

Nice To Haves

Bachelor's Degree in Microbiology, Science, or a related discipline preferred
Support and contribute in Lean Sigma programs and activities towards delivery of the set target

Responsibilities

Prepare and update Control forms, SOIs, and general lab documentation.
Independent planning and support of troubleshooting of equipment within the lab, as well as the independent organization of repairs/preventive maintenance (including supervision of external vendors, technical review of documentation); in case of technical issues problem solving and development of solution strategies.
Management and execution of own projects, proactive communication of time lines and project status as well as highlighting possible risks.
Independent creation and reporting of lab statistics.
Lead and participate problem solving teams in identification, investigation (OOS’s) and resolution of problems in the lab.
Participate and provide support in regulatory and customer audits as needed.
Develop a higher level of knowledge and skill with current and new analytical technology and techniques.
Meet individual and departmental goals as required.
Apply required cGMP regulations and follow all policies and procedures.
Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
Compliance to all 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.
Coordinate with the analytical laboratory to ensure analytical test data generated are reviewed in compliance to cGMP and DI and released in a timely manner.
Review Data of laboratory testing within notebooks and SAP.
Provide training and retraining of laboratory staff on proper laboratory cGMP procedures.
Other duties as assigned.