Title:  Laboratory Lead Design Engineer

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

Job Summary:

As the Lead Design Engineer, Laboratory, you will be responsible for performing testing and lead/manage fixture design for both internal and external customers in a cGMP environment. You will serve as subject matter expert in analysis of applicable area(s) of expertise.  You will provide technical and design leadership, evaluate, and institute new technologies relevant to qualitative and quantitative analysis and design, manage projects, provide technical assistance within and external to the department.

Essential Duties and Responsibilities:

• Lead and manage various fixture design projects, from conception and application, prototype (3D Printing), to finished product via CAD programing and adherence to internal instruction.
• Be an expert on technical laboratory analysis and interpretation, assisting in drafting of various documentation. Develop, validate, and perform testing as assigned through client reporting. Make recommendations for improvements and optimization as appropriate.
• Lead statistical evaluations for team. Comprehension of GR&R statistical approach is required. Compile, analyze, and report results as needed.
• Keep current with new analytical technology and research/recommend acquisitions where appropriate. Lead laboratory initiatives as instructed from management. Author technical papers that are suitable for publication.
• Work independently and as part of a team with self-motivation, adaptability, and a positive attitude. Train peers as appropriate.
• Prepare work instructions, SOPs, and qualification and technical report documentation.
• Interact with internal and external clients and lead meetings in a technical capacity.
• Lead lab investigation, OOS and OOT, as required.
• Serve as a role model with positive leadership. Support team in an operational capacity in the absence of the supervisor. Mentor others and provide technical direction.  Provide leadership for cGMP compliance and technical training.
• 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.

Basic Qualifications: 

• BS in Engineering, Physics, Chemistry or related technical degree.
• Minimum 5-10 Years of experience in a GMP Laboratory
• Advanced Degree is preferred.

Preferred Knowledge, Skills and Abilities:

• cGMP
• ISO and USP/EP compendia, Specifically ISO 11040, 11608, and USP 381, 382
• Experience with CAD Design, 3D Printing, Minitab, Zwick, Instron or Solidworks/ Solidworks PDM
• Strong oral and written communication skills and attention to detail required.
• Awareness to all relevant SOPs as per Company policy as they are related to the position covered by this Job Description

Travel Requirements:

• Must be able to travel up to 5% of the time

Physical and Mental Requirements:

• Light – 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
• 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 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 Apply.Accommodation@westpharma.com.  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.