Manufacturing Quality Engineer at West Pharmaceutical Services Cornwall Ltd

Shlomi, North District, Israel -

Full Time

Start Date

Immediate

Expiry Date

20 Jun, 26

Salary

0.0

Posted On

22 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality First Mentality, Cross-functional Work, Pilot Document Writing, Procedure Approval, Deviation Investigation, Nonconformity Analysis, Training, Sorting Support, Rework Support, GMP/GDP Standards Adherence, Production Stop/Renew, Data Integrity, CoPQ Management, Production Improvement Plans, Validation Oversight, Root Cause Failure Analysis

Industry

Pharmaceutical Manufacturing

Description

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 fully onsite role, the Manufacturing Quality Engineer will own all qualiy activities at one of the manufacturing sub-contractors, support the validation process to the contract manufacturing and provide quality oversight to the engineering department, while working within a multi-functional team environment for medical devices. The Manufacturing Quality Engineer will lead projects and tasks, from product validation through transfer to the production and play an active role to ensure products meet quality standards consistent with internal procedures and acceptance criteria. Additionally, this role will identify and implement improvements to the production processes. The Manufacturing Quality Engineer will be the products and production focal point for our sub-contractors and will be responsible for projects related to the production and machines, including training, audits, stop and renew the production. Essential Duties and Responsibilities Exhibit a strong “quality first” mentality and ensure that product and quality are held to the highest standard. Work cross-functionally with individuals or extended teams to provide guidance and ensure success of projects. Responsible to write, review and approve pilot documents (including reports). Write and approve various department and production procedures and forms. Lead investigation processes for deviations and nonconformities in production and create analysis reports. Responsible to train the sub-contractors according to QA procedures and VoE. Support special processes such as sorting or rework in production. Own all production activities at one of the subcontractors to ensure manufacturing is held according to West procedures and GMP/GDP standards Responsible for stopping and renewing production with accordance to West requirements and with MQ manager approval. Manage production related projects and act as MQ focal point in various internal and external projects- such as Data Integrity, CoPQ, production improvement plans, etc. Provide Quality oversight of validation activities and processes. Lead pilot processes that include change and approval of quality aspects in pilot protocols and reports and assure that pilot processes are conducted according to West guidance and protocols. Attend production pilot meetings as the MQ focal point. Education Bachelor's Degree in Engineering or science related- required Relevant work history and/or experience may be considered in lieu of degree Work Experience Minimum 3 years of experience in a Quality engineering role at an engineering, pharmaceutical, or medical device manufacturer- required Preferred Knowledge, Skills and Abilities Experience with production processes and process controls Experience with sub contractors interface and meeting customer expectations Experience with Medical Device, Validation Activities, Risk Management, Product Transfer to production Working knowledge of quality systems such as ISO 13485, 21 CFR 820, ISO 14971, MDSAP Must have effective problem solving and interpersonal skills Ability to work independently, multi-task and thrive in fast-paced environment Problem solving including root cause failure analysis methods Additional Requirements Minimum 3 years of experience in Medical Device Quality & Production lifecycle Experience with production processes and process controls Experience with sub contractors interface and meeting customer expectations Experience with Medical Device, Validation Activities, Risk Management, Product Transfer to production Working knowledge of quality systems such as ISO 13485, 21 CFR 820, ISO 14971, MDSAP Must have effective problem solving and interpersonal skills Ability to work independently, multi-task and thrive in fast-paced environment Problem solving including root cause failure analysis methods 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.  #LI-KR1 #LI-onsite

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Responsibilities

The Manufacturing Quality Engineer will manage all quality activities at a manufacturing sub-contractor, supporting validation processes and providing quality oversight to the engineering department within a medical device environment. This role involves leading projects from product validation through production transfer, ensuring quality standards are met, and identifying process improvements.