Lab Engineer/Scientist 2

This is an onsite position requiring the team member to be onsite 5 days a week. No relocation is provided for this opportunity.

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

• 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.

Education

• Associate's Degree in Microbiology, Science, or a related discipline required
• Bachelor's Degree in Microbiology, Science, or a related discipline preferred

Work Experience

• 3+ years of professional experience in a lab environment required
• Experience in pharmaceutical/medical device field and implementing laboratory training programs required

Preferred Knowledge, Skills and Abilities

• 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.
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target
• 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. #LI-AP1 #LI-ONSITE

Travel Requirements

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 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)

West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening.