Process Development Engineer

Aptask Global Workforce (AGW) is seeking a Process Development Engineer for an onsite position with a 12+ month contract located in Thousand Oaks, CA.

Responsibilities:

• Support senior staff in the initiation, design, and delivery of projects, particularly for automation related scope
• Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution by third party firms
• Assist with project definition by performing engineering studies and assessment for automation system installations
• Perform field evaluations of existing systems and provide engineering design recommendations
• Support ongoing hands-on lab-based development in visual inspection process development (i.e. development and maintenance of defect standards and panels, establishment of GMP procedures related to operations)
• Implement and document off-line and on-site drug product characterization studies
• Author and/or own high-quality process technology transfer and other technical documents
• Support the establishment of robust tactical and strategic objectives related to visual inspection
• Participate in cross-functional teams working effectively in a highly matrixed team environment to drive change, efficiency, and strong relationships
• Support one or more clinical and commercial process introductions or process transfers into the manufacturing network

Requirements:

• Experience with Visual Inspections
• Defect Standard Creations
• Biosafety Lab Aseptic Technique
• Master's degree
• Bachelor's degree and 2 years of engineering and/or operations experience
• Associate's degree and 4 years of engineering and/or operations experience
• High school diploma / GED and 6 years of engineering and/or operations experience

Desired skills:

• 3+ years of experience within the pharmaceutical/biotechnology industry
• Experience in development/characterization of drug product unit operations, especially visual inspections
• Understanding of process related stresses that impact the quality and stability of biologics
• Fill/finish process scale-up and technology transfer experience including the use of gap analysis, root cause analysis, and risk assessment tools
• Ability to use engineering principles to leverage bench and pilot scale models for process performance characterization
• Familiarity with cGMPs, regulatory filings, and compliance issues for sterile injectable products manufactured by aseptic processing
• Experience in a matrix team environment
• Organizational, technical problem solving, and communication (written and verbal) skills
• Ability to learn and act on dynamic information at a rapid pace
• Familiarity with electronic record keeping, GMP, laboratory notebooks, statistical analysis and software
• Laboratory or pilot plant experience with process equipment
• Experience with automation, computer programming, systems, and/or robotics

Pay range: up to $42.52 per hour

Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position.

If you have the described qualifications and are interested in this exciting opportunity, apply today!

Aptask Global Workforce (AGW)

ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.

Benefits of working with ApTask Global Workforce include:

• Medical
• Dental
• Vision
• Sick Pay (for applicable states/municipalities)

Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website https://www.agwtalent.com/.

ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.