Staff Engineer, Engineering - Individual Contributor

Dexian; Franklin (TN); On-site; USD 120,000 - 180,000; Full time

Job summary

Dexian seeks a Staff Product Transfer Project Engineer Bioprocessing to lead complex biologics technology transfer programs between CMOs and internal sites. You will oversee process development, transfer, validation, and regulatory support across sterile biologics manufacturing, with emphasis on compliance and readiness for commercial production.

The role requires strong bioprocessing knowledge, at least 4 years in biotech or pharma, and experience working with CMOs in FDA-regulated

Qualifications

• Strong understanding of biologics manufacturing and bioprocessing.
• Experience with FDA/EMA/ICH and cGMP regulatory environments.
• Proven ability to lead cross-functional teams through tech transfer.

Responsibilities

• Lead end-to-end bioprocess technology transfer activities including scale-up and qualification.
• Serve as engineering liaison between CMOs and internal teams (Regulatory, QA, Manufacturing).
• Coordinate risk assessments (e.g., FMEA) and support regulatory submissions.
• Manage ECOs/change controls and ensure timely, compliant transfer activities.
• Support analytical method transfers, IQ/OQ/PQ, and PPQ campaigns.

Skills

Bioprocessing knowledge

Project management

Regulatory understanding

Communication skills

Education

MS or PhD in Chemistry/Biochemistry/Pharmaceutical Sciences/Biotechnology/Engineering

Job description

• The Staff Product Transfer Project Engineer Bioprocessing provides technical leadership for complex biologics manufacturing technology transfer programs between Contract Manufacturing Organization (CMOs) and internal manufacturing sites.
• The role supports sterile injectable biologic drug products by leading engineering activities and providing technical support across process development, transfer, qualification, validation, regulatory support, and commercial manufacturing readiness.

Key Skills and Knowledge

• Strong understanding of biologics manufacturing, upstream and downstream bioprocessing, sterile manufacturing, single-use systems, protein formulation, stability, and analytical methods.
• Working knowledge of FDA, EMA, ICH, cGMP requirements, process validation lifecycle, regulatory submissions, and post-approval manufacturing changes.
• Excellent project management, technical writing, communication, organizational, and stakeholder-influence skills in highly regulated environments.

Key Responsibilities

• Lead end-to-end bioprocess technology transfer activities, including process adaptation, scale-up, equipment qualification, validation, and commercial readiness.
• Serve as the primary engineering liaison between external manufacturing partners and internal Technical Operations, Regulatory Affairs, Quality, Manufacturing, Supply Chain, and Validation teams.
• Collaborate with internal cross-functional teams and external partners to lead technical discussions, resolve issues, communicate project status, risks, and recommendations to leadership, and ensure successful execution of transfer activities.
• Conduct engineering gap assessments and technical risk evaluations using structured methodologies such as FMEA.
• Support regulatory submissions, Biologics License Application (BLA) supplements, inspection readiness, and technical justifications related to manufacturing transfers.
• Support analytical test method transfers activities, IQ, OQ, PQ, GMP, non-GMP, engineering, and PPQ campaign execution, including review of protocols, reports, batch records, and technical documentation to ensure compliance with regulatory expectations, quality standards, and project timelines.
• Manage engineering change strategies, ECOs, and documentation release activities through change control systems.
• Perform other duties as assigned to support Product Transfer and Technical Operations.

Required Qualifications

• Preferred M.S. or Ph.D. in Chemistry, Biochemistry, Pharmaceutical Sciences, Biotechnology, or Engineering; B.S. considered with significant relevant experience.
• Minimum 4 years of engineering experience in biotechnology, biologics, pharmaceutical, or medical device industries.
• Minimum 4 years supporting technology transfer, manufacturing engineering, process engineering, validation, or scale-up in FDA-regulated cGMP environments.
• Experience working with Contract Manufacturing Organization (CMOs) and scientific leadership experience in GMP biologics manufacturing are preferred.

Desired Skills and Experience

• The Staff Product Transfer Project Engineer Bioprocessing provides technical leadership for complex biologics manufacturing technology transfer programs between Contract Manufacturing Organization (CMOs) and internal manufacturing sites.
• The role supports sterile injectable biologic drug products by leading engineering activities and providing technical support across process development, transfer, qualification, validation, regulatory support, and commercial manufacturing readiness.

Dexian stands at the forefront of Talent + Technology solutions with a presence spanning more than 70 locations worldwide and a team exceeding 10,000 professionals. As one of the largest technology and professional staffing companies and one of the largest minority-owned staffing companies in the United States, Dexian combines over 30 years of industry expertise with cutting-edge technologies to deliver comprehensive global services and support.

Dexian connects the right talent and the right technology with the right organizations to deliver trajectory-changing results that help everyone achieve their ambitions and goals. To learn more, please visit https://dexian.com/.

Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.