Process Engineer- Mfg (US) – CooperVision, Inc

Job Description

JOB TITLE: Senior Process Engineer

JOB SUMMARY

Provides technical expertise in supporting a variety of manufacturing processes to achieve the targeted performance levels for the overall site and wider business objectives. Provides manufacturing process and project engineering support including process development, validation, and continuous improvement activities. Supports the wider business in the introduction of new products and automated processes into manufacturing, working closely with global support groups. Supports the training and on-going development of the Process Engineering function.

ESSENTIAL FUNCTIONS

Essential Functions & Accountabilities:

• Leads initiatives for the installation, development, and validation of manufacturing processes from concept to implementation.

• Provides on-going support and monitoring to the manufacturing organization in achieving objectives in respect of process performance, yield, cost, and product quality.

• Identifies process problems to gain root cause, evaluating data from a variety of sources, formulates alternative solutions, selects, and implements the best solution.

• Leads corrective action through troubleshooting activities where issues arise across various manufacturing disciplines providing corrective action to resolve disruptions.

• Leads cross-functional teams through formal problem-solving events resolving systemic issues utilizing Corrective Action Preventive Action (CAPA) methodology.

• Seeks to identify areas for Improvement in process yield, cost, and product quality. Leads improvement projects and the implementation of improvements across manufacturing operations as appropriate.

• Helps develop and maintain production related documentation, ensuring said documents are accurate, up to date and reflect current GMP (cGMP).

• Leads process and product validation activities including the construction and delivery of validation protocols and arising reports. Ensures that the validation process and procedures are fit for purpose and compliant with current regulatory requirements.

• Actively supports the development of the Process Engineering group, assists with engineer training and development and is available for support on an as required basis.

• Manages the receiving of new products and processes into site manufacturing to ensure the most efficient transfer.

• Leads manufacturing improvement events driving Lean initiatives to improving processes utilizing various toolbox items. (6S, VSM, Kaizen, Visual Mgmt, Poka-yoke, 3P, …)

• Always considers the potential business impact of specific actions and decisions for the company, and consistently directs efforts to preserve and enhance its business position.

POSITION QUALIFICATIONS

KNOWLEDGE, SKILLS AND ABILITIES

High volume Manufacturing process engineering and optimization experience.

• Proficient in the definition and optimization of manufacturing processes, including creation of appropriate documentation, with demonstrated results in the following areas:

o Lean manufacture

o Continuous improvement

o OEE

o Risk Management

o DMAIC

• Builds and maintains close working relationships with both manufacturing and functional support teams to create and deliver workable and sustainable solutions.

• Demonstrates a clear understanding of the demands within the business, and the need to supply sustainable engineering solutions.

• Highly competent in various automation disciplines with demonstrated success in transfer and install of manufacturing equipment into production, adhering to medical device regulations.

• Demonstrated validation expertise including FAT, SAT, IQ-OQ-PQ, process characterization, and proven reporting capability.

• Competent in Quality Assurance and Quality Control systems, ideally from medical device/pharmaceutical industry, GAMP and appropriate regulatory requirements.

• Health and Safety experience in respect of safe working practice, use of equipment/guarding, mechanical handling, NFPA/OSHA or CE marking.

• Proven project management and reporting skills with the ability to communicate effectively at all levels. Demonstrated experience as a first line leader managing complex projects.

• Motivated team player with a can-do attitude having the ability to effectively lead projects and improvement activities, delivering workable and sustainable solutions.

• Experience of IT systems hierarchies – ERP, Manufacturing control systems, SCADA, PLC.

• Demonstrated analytical and problem-solving skills, PFD, FMEA / risk assessments, Lean Six Sigma, Design of Experiments and Statistical Process Control.

• Demonstrated use of Mini tab and/or advanced Excel proficiency supporting data analysis.

• CAD experience preferred, Solidworks and Autocad platforms a plus.

• IT proficient with Microsoft applications, Outlook, Office, Project etc…

WORK ENVIRONMENT
• Flexibility required in supporting CooperVision sites and activities, supporting additional working when required to meet the needs of the business.
• Based in an office environment and working within manufacturing and areas of specified environmental cleanliness, fast moving machinery, materials and products.
• Minimal travel may be required, estimated at 1-2 weeks per year.

EDUCATION

• B.S. in Mechanical or Manufacturing Engineering or related engineering discipline.

• Desired Certification: Lean Manufacturing or Six Sigma

EXPERIENCE
• Minimum of 7-10 years’ experience with progressive assignments in automated machine development, qualification and continuous improvement in a manufacturing environment
• Desired Experience: Medical device manufacturing or other regulated industries (e.g ISO9001, ISO 13485, MDSAP).