Engineer II, Manufacturing Engineering

Summary:

TheEngineer II, Manufacturing Engineer role is a part of the Engineering staff. The Engineering team uses engineering principles and process knowledge to fulfill critical roles in a curent Good Manufacturing Practices (cGMP) pharmaceutical environment. Primary responsibly is to provide support of manufacturing process equipment operation, maintenance and improvement.

Essential Functions:

Completes required reactive, preventative and predictive maintenance of process equipment. Troubleshoots process equipment by diagnosing and resolving difficult hardware, software, instrument, and process problems to maintain system readiness. Assists in troubleshooting of process equipment and supports process investigations. Supports the implementation of new process equipment, including commissioning test protocols, punch-list execution, administrative documentation and training. Assists in factory acceptance protocols (FATs) and site acceptance protocols (SATs) for new equipment – some travel required. Supports the Project Engineering, Manufacturing and Process Development groups in the design, documentation (User Requirement Specification (URS), Process Descriptions, and Equipment Specs) and purchase equipment. Utilizes risk-based approaches to lead preventative and predictive maintenance programs for process equipment. Supports process equipment needs and other general site equipment needs when required. Provides technical evaluation and input for Quality Assurance initiatives. Supports the validation of equipment, Standard Operating Procedures (SOP) generation, general process layout and flow. Works with procurement to develop equipment vendor relationships and assist in bid evaluation to ensure best pricing on new equipment / parts. Works closely with site project engineers to ensure that critical utility systems are appropriately designed for new process implementation. Participates in Practical Process Improvement (PPI) teams to support site continuous improvement initiatives. Works in a safe and responsible manner and obeys all safety policies and procedures. Complies with all job-related safety and other training requirements. Performs other duties as assigned.

Education:

Technical degree in engineering, instrumentation, process automation or related discipline. Bachelor degree required.

Experience:

Two years of relevant experience required. Biotech, pharmaceutical or other regulated industry preferred.

Equivalency:

Equivalent combinations of education, training, and relevant work experience may be considered.

Competencies:

Good knowledge of current Good Manufacturing Practices (cGMP) preferred. Ability to troubleshoot complex processes, instrumentation and associated control systems required. Experience with facility utility systems preferred. Strong proficiency in Microsoft Office Suite required (Word, Excel, Visio and PowerPoint), as well as AutoCAD and MS Project preferred. Good knowledge of computer control system start-ups, loop tuning, troubleshooting, and control system modifications. Familiarization of PLC ladder logic, IO networks, control computers and associated control components preferred. Effective written and interpersonal skills. Ability to work on multiple projects simultaneously.

Physical Requirements:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

Disclaimer:

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.