Job Description

Process Engineer/ Scientist III

Framingham, MA

12 Months

Description:

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

The Process Engineer IV role is expected to

• Provide technical leadership in area of responsibility. Provide technical/scientific support, expertise, and guidance to manufacturing and quality.
• Ensure a solid understanding of engineering principles and theories in the area of responsibility and uses them to solve a range of complex problems in creative and practical ways.
• Lead technical project team or cross-functional team between groups/organizations. Provide input and coordinates support from process development teams.
• Review manufacturing processes and/or development and production data.
• Design and conduct necessary experiments; contributes to understanding and interpretation of results; recommend changes or additional experiments.
• Support documentation preparation for regulatory purposes and stay current on regulatory requirements that have impact on manufacturing processes and evaluate/implement changes if required.
• Provide CMC support and guidance for product life cycle management.
• Attend trainings and scientific meetings to remain current with technology and regulatory guidelines.
• Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs.

BASIC QUALIFICATIONS

Bachelor’s Degree in Chemical or Biochemical Engineering, or related engineering disciplines with 7 years of relevant experience in the biopharmaceutical or pharmaceutical related industry

OR

Master’s Degree in Chemical or Biochemical Engineering, or related engineering disciplines with 5 years of relevant experience in the biopharmaceutical or pharmaceutical related industry

OR

Doctor’s Degree in Chemical or Biochemical Engineering, or related engineering disciplines with 3 years of relevant experience in the biopharmaceutical or pharmaceutical related industry

PREFERRED QUALIFICATIONS

• Demonstrated expertise applying fundamental principles to real world problem solving and providing practical solutions to difficult technical issues.
• Experience with biologics downstream unit operations, Filtration, UF/DF, Chromatography, Viral clearance, and leachable and extractables.
• Understand cGMP concept and familiar with quality and regulatory framework.
• Proficient in process data analytics
• Knowledge of computerized systems in biopharmaceutical manufacturing environment, i.e., Distributed Control System, Process Data Historian, LIMS, and MES.
• Experience leading projects and/or cross functional teams.
• Works independently with minimal supervision and direction. Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion.
• Ability to navigate ambiguous circumstance to meet final objectives.
• Strong communication and technical writing skills. Experience communicating with business partners and senior management.

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