Job Description:

Work Schedule

Standard (Mon-Fri)



Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Loud Noises (Equipment/Machinery), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Various outside weather conditions, Will work with hazardous/toxic materials



Job Description



As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.




Location/Division Specific Information



Reports to the Chelmsford, MA site, and supports the Purification and Pharma Analytics (PPS) Business unit.



Shift Schedule: Monday-Friday, Standard Day Shift, 8 hours between 6 AM - 6 PM. Remote support on weekends/nights occasionally. Schedule flexibility required.




Discover Impactful Work:



The Manufacturing Engineer III is a leader and role model for the Sustaining Engineering team. We seek an upbeat individual with communication, leadership, technical and operational skills to join our team. You will lead Chelmsford site projects for equipment/utilities commissioning and qualification activities, process validations, and enable top-line growth for the PPA business. Empower operations teams to implement continuous improvement solutions and tackle critical problems for operations barriers.




A Day in the Life:

• Work with various departments and customers to ensure smooth scale-up, technology transfer, and validation alignment.
  
  


• Mentor junior-level engineers in career development and talent growth
  
  


• Prepare protocols for validation or performance testing of new or modified manufacturing equipment, processes, or systems.
  
  


• Own change control management for new and existing chemical processes by generating process flow diagrams, SOPs, and pre-operations packages including HAZOPs, PHAs, pFMEAs, and risk assessments.
  
  


• Optimize process variability using data-based statistical models and in-process trending.
  
  


• Facilitate material disposition review for POROS Manufacturing.
  
  


• Drive investigation and root cause analysis of production issues to enable CAPA development.
  
  


• Verify efficiency and stability of post-validation states in production.
  
  


• Collaborate and coordinate with collaborator and site collaborator groups for critical business decisions.
  
  


• Develop, maintain, and build key department trainings for improved onboarding and team development.
  
  


• Lead validation activities for plant expansions, scale-ups, and process improvement projects.
  
  


• Lead projects tied to annual business strategy and objectives.
  
  


• Maintain and support a safety and quality culture.
  
  

Keys to Success:





Education

• Bachelors degree in Science, or related field required. Master's degree in Chemical Engineering (or similar engineering field) preferred.
  
  

Experience

• 4 years of manufacturing engineering/support experience required with a BS degree, or 2 years experience will be accepted with a Master's degree.

Knowledge, Skills, Abilities

• Knowledge of current Good Manufacturing Practices (cGMP) and safety (OSHA) regulations desirable.
  
  


• Good understanding of ISO 13485 requirements.
  
  


• Familiarity working in a Class I Div II Hazardous Location Manufacturing Environment.
  
  


• Exposure to batch chemical manufacturing processes.
  
  


• Experience with the following systems: Delta V (Process Control System), OCPLM (Change Order Management), Trackwise (Problem Reporting and RCCM software).
  
  


• Proficient in continual process improvement practices such as Kaizens, Gemba, 3P, 5S, Standard Work and others.
  
  


• Excellent communication and interpersonal skills with good attention to detail.
  
  


• Ability to produce and present original technical communication materials for internal and external audiences.
  
  

Benefits



We offer competitive remuneration, annual incentive plan bonus scheme, 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. Apply Now