To Discuss more about this job opportunity, please reach out to Deepak Arya (LinkedIn URL www.linkedin.com/in/deepakarya8a79aa22a/), email your updated resume at Email deepak.arya@collabera.com. Thank you!

Pay Range: $22 to $26 an hour.

Industry: Pharmaceutical

Work Type: Onsite

Duration: 12 Months Contract (Possibility of Extension)

Job Summary:
We are seeking a Process Development Engineer to support aseptic drug product manufacturing and process development activities within a large biotechnology environment. The role focuses on process characterization, technology transfer, manufacturing support, and troubleshooting for sterile injectable products. Candidates will execute experiments, analyze technical data, and collaborate with cross functional teams to improve process efficiency and product quality. This position requires strong experience in fill finish operations, statistical analysis, and process scale up activities within a regulated GMP environment. The ideal candidate will bring a hands on technical background and strong problem solving capabilities in pharmaceutical manufacturing operations.

Key Responsibilities:

• Design and execute experiments supporting drug product and fill finish process development activities
• Analyze process performance data and communicate findings through technical reports and presentations
• Support aseptic manufacturing operations including troubleshooting and process improvement initiatives
• Perform root cause analysis and product impact assessments for manufacturing deviations and nonconformance investigations
• Support technology transfer and process introduction activities across manufacturing sites
• Author and review technical protocols, reports, and regulatory support documentation
• Collaborate with Manufacturing, Quality, Regulatory, Analytical Sciences, and Process Development teams
• Utilize statistical analysis software and scientific principles to evaluate process performance
• Maintain accurate GMP documentation and electronic laboratory records

Required Qualifications:

• Bachelor’s degree in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences, Chemistry, Biotechnology, or related scientific discipline with relevant industry experience
• Experience in aseptic fill finish manufacturing or manufacturing technical services
• Experience with process characterization, process scale up, and technology transfer activities
• Knowledge of sterile manufacturing operations including filtration, filling, mixing, stoppering, and visual inspection
• Experience using root cause analysis and risk assessment methodologies including FMEA and Fishbone analysis
• Understanding of cGMP regulations and sterile injectable manufacturing processes
• Strong technical writing, communication, and cross functional collaboration skills

Preferred Qualifications:

• Master’s degree in a related scientific discipline
• Experience with DOE and QbD methodologies
• Laboratory or pilot plant equipment experience
• Experience supporting regulatory filings for sterile injectable products
• Exposure to advanced AI technologies, generative AI, LLMs, or in silico modeling
• Knowledge of biologics stability and process related stress impacts

Benefits: The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, longterm disability insurance, shortterm disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually AS Applicable)