1 Senior Bioprocess Development Engineer - Pharma Expertise Job in Framingham, MA
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Senior Bioprocess Development Engineer - Pharma Expertise
$109k-129k (estimate)
Contractor
1 Week Ago
CONFLUX SYSTEMS is Hiring a Senior Bioprocess Development Engineer - Pharma Expertise Near Framingham, MA
DescriptionIn this role, you will be instrumental in developing process design basis, which includes the sizing and selection of equipment, mass balance, User Requirement Specifications (URS), and instrumentation for robust process control. You will provide input to industrialization strategies and rationale for critical process parameters, acting as a Subject Matter Expert (SME) for development and validation, health authority inspections, and investigations.
Your responsibilities will encompass process design and continuous improvements, supporting the execution and documentation of development and/or validation studies. You will lead or supervise groups and task forces in planning engineering, investigational definitions, and process validation runs. Additionally, you will document and interpret study results with actionable recommendations.
Responsibilities
Your responsibilities will encompass process design and continuous improvements, supporting the execution and documentation of development and/or validation studies. You will lead or supervise groups and task forces in planning engineering, investigational definitions, and process validation runs. Additionally, you will document and interpret study results with actionable recommendations.
Responsibilities
- Provide technical leadership as a subject matter expert in multiple areas of responsibility.
- Execute life-cycle design and industrialization of upstream processes, products, and associated test methods for Phase 3 and licensed products, including new vaccines and biopharmaceuticals.
- Partner with engineering to ensure the industrial implementation of process design, including reviewing engineering design documents and providing input to Commissioning & Qualification (C&Q) strategies.
- Offer technical assistance to manufacturing and quality operations for process troubleshooting and health authority inspections to achieve site metrics ( QDCI).
- Document and interpret study results with recommendations.
- Bachelor's Degree or Advanced Degree in chemical or biochemical engineering.
- Advanced degree in sciences with large-scale process equipment design, scale-up implementation, and validation experience.
- Expertise in one or more upstream process unit operations typically used in biotech/vaccine manufacturing (e.g., seed expansion, viral growth, egg processes, harvest/clarification).
- Knowledge of computer software common to the mission (e.g., AutoCAD, process simulation/scheduling, CFD) is preferred.
- Proficient with structured methodologies such as Good Engineering Practices, Quality by Design, Design Space, and Process Control Strategies.
- Strong analytical skills for troubleshooting and root cause analysis.
- Ability to work in cross-functional teams and communicate effectively with internal and external team members.
- Experience in equipment start-up, qualification, and validation is preferred.
Job Summary
JOB TYPE
Contractor
SALARY
$109k-129k (estimate)
POST DATE
09/08/2024
EXPIRATION DATE
10/05/2024
WEBSITE
conclavia.net
HEADQUARTERS
Cumming, GA
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