Process Engineer

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. Lead lifecycle management and process validation activities, including authoring and approving PV strategies, supporting PPQs, evaluating process changes, and maintaining regulatory alignment during program transition from clinical to commercial phases.

Payrate: $60.00 - $60.00/hr
 
Summary:
The MS&T Process Engineer provides technical leadership and support to Princeton, NJ cGMP manufacturing facility that ensures cell therapy processes are robust, scalable and cGMP compliant. The MS&T Process Engineer drives seamless technology transfer, reliable cGMP manufacturing, and continuous improvement to enable the site to deliver safe, high-quality therapies to patients with speed, precision, and operational excellence.
 
Responsibilities:

• Process Subject Matter Expert (SME) and process owner for technology transfer and new product introduction.
• Perform technology transfer facility, process, workflow, and equipment fit assessment, process gap analysis, and process risk assessment when on-boarding new programs.
• Author, review, and approve internal cGMP technical documents (e.g., Batch records, SOPs, Sample Plans, and protocols).
• Author and approve protocols and reports per internal and external regulatory expectations.
• Provide on-the-floor technical support to manufacturing including process execution and troubleshooting, Quality Event triage, root cause analysis, and CAPA implementation.
• Compile, trend, analyze, and summarize cGMP manufacturing data using processing trending and statistical analysis tools.
• Identify and implement process improvements and operational efficiencies using data driven approaches.
• Represent MS&T as the technical Subject-Matter-Expert on internal and client-facing project teams.
• Assist Manufacturing and Supply Chain with new equipment introduction and new material assessment and onboarding.
• Support equipment and systems validation activities, including review of equipment qualification documents, drafting User Requirement Specifications, and providing technical input for impact assessments.
• Lead lifecycle management and process validation activities, including authoring and approving PV strategies, supporting PPQs, evaluating process changes, and maintaining regulatory alignment during program transition from clinical to commercial phases.
• Work with Process Development to identify, test, and implement new technologies and capabilities for the cGMP manufacturing facility.
• Identify and maintain relationships with vendor representatives of supplies, instruments, and equipment.
• Support site-wide measurement of KPI’s related to Delivery, Cost, Quality, and Safety.
• Assist with the training of new employees as needed.
• Some travel will be required.
• Other job duties as assigned.

 
Qualifications & Skills:

• BSc and/or Advanced degree in Science or Chem/Bio Engineering
• Minimum 5 years of industry experience.
• Minimum 3 years relevant experience in cGMP biologic/cell therapy manufacturing, technical or process development role.
• Advanced degree(s) preferred.
• Scientific understanding in bioprocessing principles. Familiarity with cell therapy processes, cleanroom facilities and equipment is strongly preferred.
• Demonstrated understanding of Title 21 CFR Part 11 and 21 CFR Parts 210 and 211 cGMP regulations, including their application to cGMP facilities, personnel training, equipment, materials, records, documents, manufacturing processes, packaging, and labeling.
• Experience in equipment and process qualification and validation strategies and methodologies.
• Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities is a huge plus.
• Experience with program management software and tools are a plus.
• Proficient in MS Office applications (Word, Excel, PowerPoint, and Outlook).
• Experience with data aggregation, processing and analysis software and tools and/or statistical software applications is a plus.
• Experience with Data Historian and Distributed Control Systems is a plus.
• Experience working with external parties and/or cross-functional teams.
• Experience interfacing with clients.
• Possess strong verbal/written communication skills and ability to influence at all levels.
• Ability to think strategically and to translate strategy into actions.
• Ability to prioritize tasks in a highly dynamic environment.
• Employee is required to sit or stand for long periods of time while fully gowned in a grade B attire.

 
Pay Transparency: The typical base pay for this role across the U.S. is: $60.00 - $60.00/hr. 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, dental, and vision 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.

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