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Engineer

Aditi Consulting

Thousand Oaks, CA

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JOB DETAILS
SALARY
$32–$34 Per Hour
SKILLS
Analysis Skills, Antibodies, Artificial Intelligence (AI), Automotive Automation, Biochemistry, Biological Processes, Business Administration, Cell Cultures, Change Control, Chemical Engineering, Chromatography, Communication Skills, Consulting, Current Good Manufacturing Practice (cGMP), Documentation, Drug Development, Drug Manufacturing, Drug Products, Engineering, GMP (Good Manufacturing Practices), High School Diploma, Identify Issues, Manufacturing, Manufacturing Operations, Manufacturing/Industrial Processes, Messaging Technology, Multitasking, Operations Processes, Presentation/Verbal Skills, Problem Solving Skills, Process Analysis, Process Development, Process Engineering, Process Improvement, Process Manufacturing, Product/Service Launch, Purchasing/Procurement, Regulations, Reporting Skills, Short Messaging Service (SMS), Speech Technology, State Laws and Regulations, Statistics, Team Player, Technical Presentation, Technical Support, Technical Writing, Telephony, Trend Analysis, Writing Skills
LOCATION
Thousand Oaks, CA
POSTED
16 days ago
Payrate: $32.00- $34.00/hr.
 
Summary:
We are Seeking a Process Development Engineer to join the Drug Substance Technology Engineering team at our Cambridge site. Providing strong process engineering/ technology transfer support of human therapeutic drug substance products in clinical development through commercial production. Our mission is to translate developmental processes to commercial reality for patients through scientific expertise and engineering innovation. Knowledge of processes/equipment; scale-up factors, process deviations, quality attributes. GMP experience is a plus.
 
Responsibilities:
  • Transfer processes for drug substance manufacturing and translate process improvements from the laboratory into manufacturing facilities
  • Provide technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operations. Experience is technical report writing an expectation.
  • Assist in troubleshooting clinical and commercial runs
  • Execute data trending and statistical process analysis
  • Support technical direction for process-related deviations, CAPAs, and change controls
  • Identify and support process-related operational excellence opportunities
  • Represent process development and collaborate with other functions such as Manufacturing, Quality, and Regulatory.
  • Experience related to Process characterization for manufacturing of biologics highly preferred. This includes technical support for authoring and reviewing process characterization reports.
 
Basic Qualifications:
  • Master’s degree and 2 years of Engineering or Operations experience
  • Bachelor’s degree and 4 years of Engineering or Operations experience
  • Associate’s degree and 7 years of Engineering or Operations experience
  • High school diploma / GED and 8 years of Engineering or Operations experience
 
Preferred Qualifications:
  • Master’s degree in chemical or Biochemical Engineering
  • 2+ years of Process Engineering experience preferably related to downstream/ purification of commercial cGMP manufacturing facilities
  • Background in biologics technology transfer into commercial facilities, new product introductions (NPIs)
  • Biologics purification process knowledge: Knowledge of upstream (cell culture/bioreactor operations) or purification processes (chromatography, viral filtration/inactivation, ultrafiltration/diafiltration, and final fill. )/ equipment; scale-up factors, process deviations, quality attributes
  • Strong analytical capability, troubleshooting, and problem solving
  • Independently motivated with ability to multi-task and work in teams, especially if remote or hybrid.
  • Excellent written and verbal communication skills with technical writing and presentation experience. Experience in PC documentation, report reviews and technical writing preferred.
 
Must Have Skills:
  • Cell culture experience, Purification /downstream experience, process characterization experience
 
Nice to have Skills:
  • Monoclonal antibodies or MBA
  • Manufacturing or on floor support
 
Pay Transparency: The typical base pay for this role across the U.S. is: $32.00- $34.00/hour. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, denmatch, lifeion benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match,  life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law. 
 
Consent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. These communications may include information about potential opportunities and information. Message and data rates may apply. Message frequency may vary.
You represent and warrant that the email address(es) and/or telephone number(s) you provided to us belong to you and that you are permitted to receive calls, text (SMS) messages, and/or emails at these contacts. You also acknowledge and agree to Aditi Consulting LLC’s use of AI technology during the sourcing process, including calls from an AI Voice Recruiter. AI is used solely to gather data and does not replace human-based decision-making in employment decisions. Calls may be recorded.
 
Consent is not a condition of purchasing any property, goods, or services. You may revoke your consent at any time by replying “STOP” to messages or by contacting privacy@aditiconsulting.com.
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy .
 
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