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Process Engineer II (Engineering)


Location: Framingham, Massachusetts
Job Category:

Description:
DEPARTMENT DESCRIPTIONS
Manufacturing Science is a partner of biologics manufacturing operations and is the custodian of manufacturing processes. Manufacturing Science ensures manufacturing processes are capable, compliant, in control, cost effective, and continuously improved.
• Provide collocated technical leadership at manufacturing sites including process monitoring,
CPV, root cause investigation, change assessment, debottlenecking, and continuous
improvement
• Anticipate, respond to, and permanently resolve issues that arise during production.
• Aid in design of new processes and facilities with expertise in scale up, manufacturability, PAT, capacity analysis, and cost analysis.
• Lead the creation and use of digital process data analytic systems.
• Partner with internal and external functions to identify, prioritize, scale up, transfer, implement,
validate, and file new product and process life cycle improvements.
KEY RESPONSIBILITIES
Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs.
• Reviews manufacturing processes and/or development and production data
• Designs and conducts necessary experiments, interprets results
• Recommends changes or additional experiments to improve quality, productivity, recovery, and overall efficiency.
• Trains manufacturing staff on new or changed processes and the use of equipment.
• May provide technical guidance to less experienced staff.
• Interacts with colleagues from various functions, such as Engineering, Manufacturing, and
Quality departments.
• May lead small technical project teams and implement project plans.
• May lead technology transfer efforts of small project teams between groups/organizations.
BASIC QUALIFICATIONS
Bachelor’s Degree in engineering or science with 3 years of experience
OR
Master’s degree in engineering or science with 1 year of experience

LEADERSHIP QUALIFICATIONS
N/A
PREFERRED QUALIFICATIONS
• Proficient in Microsoft Word, Excel, and PowerPoint
• Experience in biotechnology or the pharmaceutical industry
• Experience in purification, cell culture, or analytical methods
• Familiarity with root cause analysis and/or risk assessment
• Knowledge of DeltaV automation
• Experience working with statistical analysis software
• Experience with project leadership
• Experience communicating with cross functional teams
• Effective communication skills
• Strong technical writing skills
• Experience with high level data analysis
SPECIAL WORKING CONDITIONS
• Ability to lift weight
• Ability to gown and gain entry to manufacturing areas

 

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