Senior Controls Engineer

MAIN PURPOSE OF ROLE

Supports production and process development from concept through sustained manufacturing of FDA regulated products. Responsible for production support, maintenance support, performing process development and qualification, equipment specification, acquisition, installation, and integration.

MAIN RESPONSIBILITIES

•Interface with internal customers to provide controls support for manufacturing and testing equipment

•Support the development and maintenance of automated equipment

•Evaluate process and design alternatives based on Design for Manufacturability principles.

•Establish knowledge base of new developments in manufacturing and design technologies.

•Interface with vendors on procuring materials, services, and equipment

•Assemble and evaluate automated equipment

•Establishes machine specifications.

•Support equipment validations

•Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

•Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

•Evaluates machine logic, electromechanical systems and process controls to troubleshoot equipment and identify process improvement opportunities.

May conduct design analysis on components and/or assemblies to assist in the development process by ensuring designs are cost efficient, manufacturable, and reliable.

•Communicates with the other engineering personnel to coordinate the interrelated design and assure project completion.

•May act as internal consultant providing technical guidance on most complex projects.

•This is a non-supervisory position.

•Coordinate and participate in equipment Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT), etc.

 • Programming and integration of controls hardware and software into new and existing manufacturing equipment.

•Analyzes current equipment for process suitability and provides detailed plans for improvement

•Creates and revises manufacturing documents, specifications, standard operating procedures (SOPs), safety instructions, validation protocols, risk assessments, and procedures and other technical documents to ensure compliant, efficient and safe procedures.

•Lead cross functional project teams and coordinate activities

QUALIFICATIONS

Minimum 5 years

5-10 years as automation controls engineer.

Must have experience with designing and fabricating automated production equipment for low and high volume processes. Good communication skills and the ability to interact with all levels of the organization.   Experience with general automation and control concepts along with machine vision systems, robotics, and PLC software programming.

Experience working in a broader enterprise/cross-division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail. Ability to travel, including internationally.