Senior Associate Process Engineer (Contract)

elevatebio; Waltham (MA); On-site; USD 59,000 - 79,000; Full time

Job summary

ElevateBio is seeking a Senior Associate Process Engineer in MSAT to provide process science support for GMP manufacturing, tech transfers, development studies, and continuous improvement across cell and gene therapy modalities. You will contribute to protocols, product impact assessments, root-cause analyses, and technical reports while working with a cross-functional team.

The role requires a life sciences or engineering degree, 3+ years in MSAT or related areas, and familiarity with GMP

Qualifications

• Bachelor’s degree in life sciences, engineering, biotech, or related field.
• 3+ years in MSAT, manufacturing, or process development.
• Knowledge of biotech pharma manufacturing, aseptic processing, and cell culture.
• Experience in cell and gene therapy and aseptic processing preferred.
• Understanding of process development, validation, lifecycle management, and licensure changes.
• Strong communication and cross-functional collaboration skills.
• Familiarity with GMP electronic systems such as Veeva or eBRs.

Responsibilities

• Support tech transfers and cGMP manufacturing for clinical and commercial programs.
• Author/review protocols, technical reports, work instructions, SOPs.
• Own deviations, investigations, CAPAs, and change controls.
• Assist root-cause analysis of process deviations with cross-functional teams.
• Support gap analyses and risk assessments for capital projects and tech transfers.

Skills

MSAT experience

Cell culture

Aseptic processing

Process development

Documentation

Cross-functional collaboration

Veeva

Education

Bachelor’s degree in Life Sciences / Engineering / Biotechnology

Tools

Veeva

Electronic batch records

Job description

ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently.

The Role:

ElevateBio is looking for a Senior Associate Process Engineer within the Manufacturing Science and Technology (MSAT) organization. As a Senior Associate Process Engineer in MSAT, you will provide process science support for GMP manufacturing, technology transfers, development studies, characterization, validation, and continuous improvement projects within a highly matrixed cross-functional team for ElevateBio programs. As part of support, you will write protocols, product impact assessments, root-cause analysis reports, and technical reports. You will additionally support data collection and charting for non-GMP and GMP batches.

Here’s What You’ll Do:

• Work cross-functionally across Process Development, Manufacturing, Quality, and Supply Chain to provide support for technology transfers and cGMP manufacturing for both clinical and commercial stage programs across modalities including cell and gene therapy, mRNA and viral vector.
• Authoring and reviewing technical documentation related to manufacturing activities including protocols, technical reports, work instructions, SOPs.
• Own and support quality events such as deviations, investigations, CAPAs, and Change Controls.
• Assist in the root cause determination of process-related deviations in a timely and complete manner. The candidate will work with a cross-functional team to resolve complex problems using experience and efficient application of scientific methodology and technical reasoning, then propose comprehensive process solutions and improvements.
• Support gap analyses and risk assessments to support the capital projects and tech transfers.

Requirements:

• Bachelor's Degree in Life Sciences, Engineering, Biotechnology, or a related technical discipline
• 3+ years of experience in a MSAT, Manufacturing, or Process Development role
• Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell culture, and process development
• Experience in cell and gene therapy, aseptic processing, and drug manufacturing preferred
• Understanding of process development, validation, and lifecycle management to support comparability studies, process validation, and licensure changes
• Strong communication skills and ability to work cross-functionally with technical and quality teams
• Familiarity with electronic systems used in GMP environments such as Veeva, or electronic batch records

The budgeted range for this position is $43/hour - $57/hour. This range is a good faith estimate of the expected hourly range for this position, based on a wide range of factors including qualifications, experience and training, operational and business needs and other considerations permitted by law.

ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.