Process Engineer II

Process Engineer II

We understand that the world we want tomorrow starts with how we do business today, and that's why we're inspired to make A Better World for Pets. Antech is comprised of a diverse team of individuals who are committed to each other's growth and development. Our culture is centered on our guiding philosophy, The Five Principles:
Quality, Responsibility, Mutuality, Efficiency and Freedom. Today Antech is driving the future of pet health as part of Mars Science & Diagnostics, a family-owned company focused on veterinary care.

Job Purpose/Overview

A Process Engineer II is required to maintain day-to-day operations in manufacturing, maintaining and improving upon existing equipment as well as ensuring product quality and yield. A Process Engineer II works closely with other teams and under the guidance of their manager to transfer and develop new products and processes. A Process Engineer II understands appropriate documentation in a regulated environment, implementing corrective actions, and experience with continuous improvement principles.

Essential Duties and Responsibilities

To perform this job successfully, an individual must be able to satisfactorily perform each essential function. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Lead efforts to provide sustaining support to operations utilizing continuous improvement principles and technical support to operations utilizing root cause analysis to implement corrective actions.
• Enables company growth by ensuring on-time equipment milestone deliveries.
• Recommends and implements equipment and process modifications to improve production efficiencies, manufacturing techniques and production yields for existing products.
• Assists in developing high level capital equipment integration protocols and procedures for manufacturing.
• Develops and conducts statistical analysis such as Design of Experiments (DOE) and Statistical Process Control (SPC) targeting physical cause of failure for yield loss and improving quality. Active database and data management allowing for process performance assessment via GR&R, Yield Tracking and Cpk analysis.
• Accurately documents all work products to ensure equipment qualifications and in line with and follow IQ, OQ, PQ requirements.
• Interacts with design staff to ensure that processes and designs are compatible with existing equipment.
• Translate design requirements into production by defining, designing and/or communicating efficient and capable process tooling.
• Utilizing GDP, author documents including but not limited to manufacturing Standard Operating Procedures (SOPs), and detailed work instructions.
• Trains manufacturing staff on proper processes to follow when operating equipment, including wave-guide instrument(s).
• Ensures that team and staff members follow safety rules and protocol.
• Other duties as assigned.

Education and Experience

• Bachelor's degree in engineering or related field required; master's degree preferred.
• Five to seven (5-7) years prior experience in an R&D or production environment with proven success of process improvement and scale-up projects.
• Experience in a regulated environment (FDA, ISO, etc.), preferred.
• Experience in project management preferred.
• Experience in the medical device field, specifically invitro diagnostics, preferred.
• Licenses or certifications such as ISO, PMP, LEAN, IFMA, MPS, Six Sigma, cGMP, preferred.

Knowledge,

Skills and Abilities

• Excellent written and verbal communication skills; able to communicate technical information to technical and non-technical staff to ensure understanding.
• Excellent problem-solving skills and demonstrated ability to collaborate in problem solving.
• Excellent data gathering and analysis skills.
• Excellent electro-mechanical equipment development and troubleshooting skills.
• Knowledge of QMS, including experience with deviation, CAPA, and other quality related objectives and requirements.
• Software use and knowledge:
  Windows, MS Office products, Solid Works (or similar).
• Able to develop effective…