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Process Analytics Engineer II
2 months ago
Humacyte, Inc. is pioneering a groundbreaking scientific technology platform, creating bioengineered products that are universally implantable and readily available, aimed at enhancing patient outcomes and revolutionizing medical practices. The organization specializes in the development and manufacturing of acellular tissues, addressing a diverse array of diseases and conditions across multiple therapeutic areas. Our innovative technology facilitates tissue repair, reconstruction, and replacement, surpassing the limitations of current care standards. Initially focusing on human acellular vessels (HAVs), we aim to penetrate various vascular markets, including trauma care, arteriovenous access for hemodialysis, peripheral arterial disease, and coronary artery bypass grafting. Future endeavors include pediatric heart surgery, cellular therapy delivery, and other novel cell and tissue systems.
Position Summary:
The MSAT Engineer - Analytics will play a crucial role in the development and execution of process analytics, process support, and control strategy activities with minimal supervision. This position entails approximately 50% focus on process analytics and 50% on process engineering support. The successful candidate will collaborate effectively with teams in Manufacturing, Engineering, Process Development, Quality Assurance, and Quality Control, leveraging strong communication and technical skills to uphold and enhance manufacturing operations.
Key Responsibilities:
- Deliver advanced support for the execution and development of the manufacturing control strategy and Process Analytics program.
- Collect, analyze, and report data trends using graphical and statistical methodologies, providing recommendations to management based on data insights.
- Establish systems and processes for data acquisition and trend analysis from processes, equipment, and raw materials.
- Utilize statistical process control techniques to independently create and implement process specifications, parameters, operating ranges, and action limits.
- Assist in the execution of commercial manufacturing campaigns.
- Guide others on complex theories and concepts related to processes, including understanding the implications of process changes and deviations.
- Proactively identify technical issues with bioprocessing equipment and recommend solutions to prevent recurrence.
- Draft standard operating procedures, reports, and protocols, obtaining necessary approvals for final documentation.
Essential Skills:
- In-depth knowledge of statistical process control methods and data interpretation.
- Familiarity with multivariate modeling techniques.
- Understanding of data engineering concepts for data collection, storage, and validation.
- Strong technical foundation in cell- and tissue-based products, with familiarity in GMP manufacturing.
- Able to troubleshoot advanced bioprocess activities and conduct optimization studies.
- Comprehensive understanding of the biological and engineering aspects of the processes involved.
- Ability to foresee potential problems and address them proactively.
General Competencies:
- Effective communication skills in English, both verbal and written.
- Positive attitude and a proactive approach to challenges.
- Ability to thrive in a dynamic team environment with shifting priorities.
- Exceptional organizational and time management skills, with the ability to prioritize tasks effectively.
- Flexibility and adaptability in a fast-paced setting.
- Basic proficiency in MS Office applications, including Word, Excel, PowerPoint, and Outlook.
- Commitment to meeting deadlines and managing peak workload periods.
- Self-motivated, organized thinker with strong interpersonal and business communication skills.
- Experience working collaboratively in cross-functional teams.
- Adherence to company policies and safety regulations in all operational areas.
Qualifications:
- Bachelor's degree in Engineering or a related field is required.
- Master's degree in a relevant discipline is preferred.
- Experience in chemical engineering, biochemical engineering, biotechnology, bioprocessing, cell therapy, tissue engineering, regenerative medicine, or process development is essential.
- A minimum of 2 years of experience in commercial manufacturing or equivalent clinical manufacturing experience is required.
- Proven experience with the Process Validation Lifecycle and Statistical Process Control methods.
- Experience applying analytical systems and computational methods in a GMP environment.
- Demonstrated ability to lead troubleshooting efforts and participate in complex problem-solving.
- Strong background in cell- and tissue-based products.
- Experience with bioprocessing deviations, change control, process optimization, and technical troubleshooting.
- Proven ability to work effectively in a team-oriented environment.
Benefits:
- Stock Options
- 401k Plan with 4% Match and no Vesting Schedule
- Comprehensive Medical, Vision, and Dental Plans
- Company-Paid Long Term/Short Term Disability
- Company-Paid Life Insurance
- 23 Days Paid Time Off (PTO)
- 10 Company Designated Holidays + 2 Floating Holidays
- Paid Parental Leave Policies
**Please note, Humacyte does not provide sponsorship at this time and does not accept unsolicited resumes from recruiters.**