Senior Validation Engineer

Who We Are:

 

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:

 

This person will work with the engineering team to develop and optimize manufacturing processes within the company. Key to this role will be to lead a team of engineers/technicians in the specification, introduction, validation and continuous improvement of equipment and processes.This person will be responsible for outlining and developing the business case for investments into the area and then the management and implementation of projects to completion.

 

Essential Duties and Responsibilities:

 

• Lead a technical team to specify, introduce, validate, and continuously improve equipment and processes.
• Maintain, improve, upgrade existing processes to maximize safety, quality, and performance
• Integrate new technology into existing processes supporting continuous improvement
• Train team members as required on best practices and changes to improve the process
• Establish and maintain metrics specific and meaningful to process
• Lead assigned process improvement projects
• Plan, schedule, or perform projects within the approved time schedules and budgets.
• Guide, coordinate, or perform modifications, improvements or validations of existing or new formulations/products, processes and equipment
• Ensure that all projects and activities are in compliance with local, regional and best practice requirements on HSE and meet other applicable authority requirements. All internal change control procedures incl. e.g. adequate risk assessment / FMEA are to be followed strictly
• Support product transfer projects between plants from a process stand-point as assigned
• Support & Manage process or technology transfer projects between plants from a process stand-point as assigned
• Support new and experimental development activities
• Support projects and initiatives stemming from the Global Process Engineering team
• Support/lead Operations Excellence lean and continuous improvement activities
• Review procedures to ensure they reflect the most effective means and contain the most current and correct information
• Maintain Process engineering records and documents as required
• Gather and evaluate In-process control data (CPP graphs, rheological data, etc.) in order to support process improvements and ensure the process Quality
• Initiate, support, execute CAPA and other quality initiatives
• Ensure compliance with cGMPs, FDA and other regulations as necessary
• Prepare reports as may be required on a routine basis or on demand within established deadlines.
• Safeguard confidential information
• Maintain effective team member relations
• Communicate on a regular basis (or as appropriate) with external suppliers of materials and equipment and provide regular feedback on any issues to the management team
• Attend, schedule, and facilitate internal meetings to help establish priorities and assign tasks.
• Coordinate the development of documentation in the Production and Technical areas in line with ISO9001 and ISO 13485 requirements and review the systems with the Group Leaders and the Quality department on a regular basis to ensure conformance to same.
• Conforms with and abides by all regulations, policies, work procedures, instruction and all safety rules
• Perform other duties as assigned based on business needs
• The job descriptions reflect the general details considered necessary to describe the principal functions of the job identified and shall not necessarily be construed as a detailed description of all of the work requirements that may be inherent in the job.

 

 

Basic Qualifications: <