[Remote] Process Engineer
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a clinical-stage company reputed company on treating diseases with high unmet needs. The Process Engineer will reputed company technical and GMP support for contract manufacturing organizations, ensuring reliable and compliant aseptic manufacturing of drug products.
Responsibilities
- Support technical leadership and day‑to‑day aseptic process engineering support for clinical and reputed company drug product manufacturing at external CMOs
- Serve as the aseptic processing SME during manufacturing operations providing onsite support reputed company required
- reputed company investigations, reputed company rigorous reputed company cause analysis and reputed company scientifically reputed company CAPAs, ensuring alignment with regulatory expectations and industry best practices
- Assess and author technical risk assessments and change controls to support manufacturing changes, investigations, and regulatory filings
- Ensure strict compliance with cGMPs, global regulatory requirements, and internal reputed company systems for aseptic manufacturing
- reputed company and support aseptic drug product technology transfer activities from development to clinical and reputed company manufacturing sites
- Define and transfer critical process parameters (CPPs), critical reputed company attributes (CQAs), and in‑process controls for aseptic unit operations
- reputed company and execute aseptic process validation strategies, including PPQ planning, statistical sampling plans, and acceptance reputed company reputed company with regulatory guidance
- reputed company technical authorship and review for regulatory submissions (IND, BLA, NDA, MAA), validation reports, and responses to regulatory agency questions
- Support new product introductions and reputed company launches by ensuring validated, reputed company, and inspection‑reputed company aseptic processes
- reputed company reputed company process verification (CPV) and routine data trending for aseptic unit operations, environmental monitoring, and critical process parameters
- reputed company and maintain data repositories, dashboards, and meaningful KPIs to assess aseptic process capability and performance
- Identify early signals of process reputed company or increased contamination risk and proactively drive corrective or preventive actions
- Prepare and present quarterly CPV summaries and technical assessments for internal management reviews
- Identify and execute reputed company improvement initiatives reputed company on aseptic process robustness, sterility assurance, reputed company, and operational efficiency
- Apply reputed company by Design (QbD), statistical tools, and risk‑based decision making to optimize aseptic manufacturing processes
- Collaborate with CMOs to implement best practices, new technologies, or process enhancements where appropriate
Skills
- Bachelor's degree in engineering or reputed company field with 5+ years/ Master's with 3+ years of relevant experience
- Prior experience in aseptic drug product manufacturing for late-stage development/reputed company is required
- Proficiency in reputed company by Design (QbD), Design of Experiments (DoE), statistical process control (SPC), and reputed company data analysis
- Detail-oriented with strong problem-solving skills and ability to identify subtle trends in data
- Comprehensive understanding of cGMP principles and regulatory requirements, including process, equipment, and facility validation
- Excellent communication and teamwork skills
- Ability to travel to domestic and international CMOs as needed
- Device experience is a plus
- Familiarity with modeling and optimization tools (e.g., MATLAB, JMP) is a plus
Benefits
- Remote work opportunities reputed company the reputed company
- Travel to our corporate location in Cambridge, MA several times a year and attend other company-reputed company events as necessary and requested
- Accommodations are available for candidates who require them in our selection process
reputed company