About this role
Description
• Support downstream process tech transfer activities from sending site or process development into GMP manufacturing, including protocol and report support, batch record review, and technical input to run readiness. • Author deviation technical impact assessments: evaluate process excursions against validated ranges and product quality attributes, and write the technical justification that supports disposition. • Draft, compile and support review of manufacturing summary reports, pulling together batch data, process performance and deviation outcomes into a coherent technical narrative. • Author and review material specifications for downstream raw materials, buffers, resins and consumables. • Perform process data review and trending across downstream unit operations, and support technical investigations arising from campaign execution. • Interface with manufacturing, QA and process development to close documentation on schedule.
Skills
downstream process, process engineer, tech transfer, deviation, downstream, Manufacturing process, process development, consumables, material specification, GMP
Top Skills Details
downstream process,process engineer,tech transfer,deviation,downstream,Manufacturing process,process development,consumables
Additional Skills & Qualifications
• BS or MS in chemical engineering, biochemical engineering, biotechnology or a related discipline. • 5 or more years of process engineering or MS&T experience in biologics drug substance manufacturing, in a GMP environment. • Hands-on technical knowledge of downstream unit operations: chromatography, depth and sterile filtration, viral clearance, tangential flow filtration and bulk drug substance handling. • Demonstrated authoring of deviation technical impact assessments or equivalent investigation documentation that passed QA review. • Direct tech transfer experience, either sending or receiving site, on at least one biologics process. • Strong technical writing. This role is documentation-heavy and writing quality is a primary screening criterion. Preferred qualifications • CDMO or multi-client manufacturing experience, where transfers run in parallel and timelines are externally driven. • Experience authoring or supporting manufacturing summary reports for client-facing delivery. • Familiarity with material specification systems and downstream raw material qualification.
Experience Level
Intermediate Level
Job Type & LocationThis is a Contract position based out of Woburn, MA. Pay and BenefitsThe pay range for this position is $75.00 - $85.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace TypeThis is a fully onsite position in Woburn,MA. Application DeadlineThis position is anticipated to close on Sep 25, 2026.About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] for other accommodation options.
San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.
Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.