West Pharma Quality Control Inspector m/f/d 

United States, North Carolina 

988368143

As the Global Equipment Compounding & Dimensioning Subject Matter Expert (SME) Leader, you will set the strategic direction and lead a team responsible for specifying, implementing, and improving equipment for weighing, mixing, and dimensioning processes in our global elastomer production facilities. You will cultivate a collaborative environment, align with cross-functional engineering teams, and drive our company’s vision for innovation and standardization in equipment processes.

• Inspire and guide the Global Compounding & Dimensioning Equipment SME team (up to 3 FTE) towards achieving organizational goals. Develop a high-performing team through mentoring and professional development.
• Lead engineering, management, plant operations and global team members while working with vendors to develop engineering specifications for new equipment or required improvements on existing.
• Shape and communicate a clear vision for advancing equipment processes, leading efforts to standardize and harmonize production equipment and associated documentation globally.
• Proactively map out and oversee team workload and project timelines to drive efficient execution of objectives, with a focus on resource optimization for new projects, corrective action/preventive action (CAPA) initiatives, and equipment development.
• Foster a culture of collaboration across various departments by working closely with Process Engineering and production teams. Facilitate the identification of innovative solutions to enhance existing systems and solve design challenges.
• Keep up to date on new and future equipment standards and trends in the market and identify value-added improvement which may be beneficial.
• Work independently, and with vendors, to understand root cause of failures, propose design or component changes, and implement and validate equipment modifications.
• Take the lead in systematic problem-solving activities if the manufacturing plants need support.
• Coordinate and/or execute all necessary GMP related validations and/or process engineering evaluations as needed for manufacturing equipment.
• Guide vendors through clear communication and task assignments. Maintain oversight on deliverables ensuring completion of Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation/Operational Qualifications (IOQ), and more.
• Champion the establishment of equipment standards aligning with global best practices to achieve unparalleled quality, efficiency, cost reduction, and safety.
• Project Management: Take the lead on equipment project management from the URS issue to PQ by applying current project managements practices including the needed GMP conform documentation.
• Research and analyze data such as vendor design proposal, specifications, and manuals to determine feasibility of design or application.
• Collaborate with cross-functional teams to follow equipment related corporate goals.
• Ensure all equipment aligns with the latest Safety Regulations.

• Bachelor’s or Master’s degree in Science or Engineering (Electrical, Mechanical, or Industrial preferred).

• Over 8 years of leadership experience in the pharmaceutical or manufacturing environments, specifically within equipment management and improvement.

• Proven track record of successful equipment project management, from specification to qualification.
• Strong engineering and trouble shooting skills.
• Proven working experience in project management.
• Demonstrated ability to manage projects in a dynamic environment with minimal direction.
• Excellent written and verbal communication skills (English & preferably a 2nd language)
• Strong strategic thinking capabilities with the ability to drive innovation and embrace change.
• Ability to drive changes and to think outside the box.
• Track record of project management excellence and great ability to perform in dynamic, autonomous environments.
• Exceptional communication skills, both in client-facing scenarios and within internal teams.
• Strong in Project and Time Management.
• Outstanding leadership and organizational skills.
• Working experience with Microsoft office products, Power BI, SolidWorks and/or other CAD systems.
• Able to comply with the company’s safety policy at all times.
• Able to comply with the company’s quality policy at all times.