Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
DESCRIPTION:
This is a day shift position for Manufacturing Support Engineer (“MSE”). This role is part of the site Engineering staff and reports into the Manufacturing Support Engineering Manager. The MSE team uses engineering principles and process knowledge to fulfill two critical roles. Provide support of manufacturing process equipment operation and maintenance as well as provides technical leadership to improve and enhance equipment robustness and process automation functions. Additionally, the MSE role is responsible for support of projects associated with new process installations, including but not limited to start-up, commissioning, mechanical/electrical installation and validation support. Each project is unique and teamwork, critical thinking and problem solving is essential for success.
REQUIREMENTS:
Leads required reactive, preventative and predictive maintenance of process and lab equipment.
Utilizes risk-based approaches to lead preventative and predictive maintenance programs for process equipment.
Troubleshoot process equipment by diagnosing and resolving difficult hardware, software, instrument, and process problems to maintain system readiness.
Provide technical leadership to improve and enhance process equipment and supports process investigations.
Supports the implementation of new process equipment, including commissioning test protocols, punch-list execution, administrative documentation and training.
Leads factory acceptance protocols (FATs) and site acceptance protocols (SATs) for new equipment – some travel required.
Supports the Tech Transfer, Project Engineering, Manufacturing and Process Development groups in the design, documentation (URS, Process Descriptions, and Equipment Specs) and purchase equipment
Supports process development lab equipment needs and other general site equipment needs when required.
Evaluates process utility requirements and leads new utility installation in conjunction with project engineers when required.
Provides technical evaluation and input for Quality Assurance initiatives.
Supports the validation of equipment, 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.
Participate 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.
Comply with all job-related safety and other training requirements.
Provide occasional off shift coverage and support weekend rotation. This can include manufacturing support over scheduled holidays.
Education
• Bachelor’s or technical degree in engineering, instrumentation, process automation or related disipline or a technical degree.
• 5+ years of relevant experience troubleshooting complex processes, instrumentation and associated control systems.
• 5+ years of experience with pharmaceutical equipment maintenance and GMP manufacturing.
Knowledge, Skills, Abilities
• Knowledge of engineering principles and skill sets including Microsoft office tools (i.e. excel, word, visio) required.
• Strong mechanical aptitude and knowledge of instrumentation and controls.
• Work attitude that exhibits drive, creativity, collaboration, assertiveness, good judgement, decision-making and ambition.
• Excellent interpersonal skills: ability to build and maintain relationships with internal and external customers; highly functioning team leader and team member in a multi-skilled, dynamic business environment.
• Leadership skills: Proven ability to influence others and lead significant changes.
• Strong communication skills both written and verbal.
• Ability to work on multiple projects simultaneously.
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Other
Relocation assistance is not provided.
Must be legally authorized to work in the United States now and in the future, without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening.
