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Process Development Engineer

Azzur Group is seeking a Process Development Engineer to join our innovative team focused on advancing manufacturing technologies within the life sciences sector. The ideal candidate will play a crucial role in developing and optimizing processes for biotechnology and pharmaceutical applications. This role combines engineering principles with scientific knowledge to improve manufacturing efficiency, product quality, and compliance with regulatory standards.

Key Responsibilities:

  • Performs experiments in small scale to assess process changes/improvements.
  • Evaluates performance and suitability of new technologies and process changes by testing and reporting different critical parameters.
  • Performs trials and experiments, participate into the design and scale-up of new technologies.
  • Conducts routine bases analytical tests to evaluate and control product yield, purity and impurity profiles.
  • Works closely with other Lab team members to support the upkeep, maintenance, and efficient utilization of the lab.
  • Write SOPs, batch records, and develop research outlines for development projects.
  • Utilize robust statistical analysis to draw appropriate conclusions from the data..

Qualifications:

  • Bachelor’s degree in Chemical Engineering, Biomedical Engineering, Biotechnology, or a related field.
  • 3+ years of experience in process development within the biotechnology, pharmaceutical, or medical device industry.
  • Knowledge of protein purification techniques.
  • Experience in protein process development.
  • Excellent problem-solving skills and ability to analyze complex data sets.
  • Ability to work in a cold environment
  • Effective communication skills for presenting technical information to stakeholders.
  • Proficiency with Microsoft Office Suite and familiarity with engineering software tools.

Preferred Qualifications:

  • Experience with DOE (design of experiments), six sigma, and lean manufacturing a plus.
  • Knowledge of regulatory requirements related to biopharmaceutical manufacturing.

Azzur Group is committed to creating a diverse environment and is proud to be an equal opportunity employer.

  • Health Care Plan (Medical, Dental & Vision)
  • Retirement Plan (401k, IRA)
  • Life Insurance (Basic, Voluntary & AD&D)
  • Paid Time Off (Vacation, Sick & Public Holidays)

Azzur Group is an equal opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

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What You Should Know About Process Development Engineer, Azzur Group

Azzur Group is on the lookout for a talented Process Development Engineer to join our dynamic and innovative team. If you have a passion for advancing manufacturing technologies in the life sciences sector, this position could be the perfect fit for you! As a Process Development Engineer, you'll be responsible for developing and optimizing processes specifically for biotechnology and pharmaceutical applications. This role brings together engineering principles and scientific knowledge to not only enhance manufacturing efficiency but also to ensure product quality and adherence to regulatory standards. Your key responsibilities would include performing experiments at a small scale to assess process improvements, evaluating the performance of new technologies, and conducting analytical tests to maintain product yield and purity. You’ll collaborate closely with lab team members for optimal lab management and will write SOPs, batch records, and develop research outlines for various projects. With a Bachelor’s degree in Chemical or Biomedical Engineering, or a related field, along with at least 3 years of relevant experience, you’ll bring in a robust problem-solving skill set and proficiency in statistical analysis. If you have experience in protein purification techniques and thrive in a collaborative environment, we want to hear from you! Join Azzur Group, where we are committed to diversity and fostering a workplace that values innovation, creativity, and inclusivity.

Frequently Asked Questions (FAQs) for Process Development Engineer Role at Azzur Group
What are the main responsibilities of a Process Development Engineer at Azzur Group?

As a Process Development Engineer at Azzur Group, your main responsibilities will involve performing small-scale experiments to evaluate process changes, assessing new technologies, conducting analytical tests for product yield and purity, collaborating with other lab members for efficient lab operations, and developing documentation such as SOPs and batch records for various projects.

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What qualifications are needed to become a Process Development Engineer at Azzur Group?

To qualify for the Process Development Engineer position at Azzur Group, candidates should have a Bachelor’s degree in Chemical Engineering, Biomedical Engineering, Biotechnology, or a related field, coupled with a minimum of 3 years of experience in process development within the biotechnology, pharmaceutical, or medical device industry.

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Does Azzur Group offer any training or career development for Process Development Engineers?

Yes, Azzur Group is committed to employee growth and offers training and development programs for Process Development Engineers. This includes learning opportunities related to regulatory requirements, lean manufacturing, and design of experiments (DOE), ensuring that you stay at the forefront of industry knowledge.

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What is the work environment like for a Process Development Engineer at Azzur Group?

The work environment for a Process Development Engineer at Azzur Group is collaborative and fast-paced. Engineers work closely with a team of dedicated professionals in a lab setting, utilizing advanced technologies and methodologies to drive innovation while ensuring high standards of safety and compliance.

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Are there any preferred qualifications for the Process Development Engineer position at Azzur Group?

Yes, while a Bachelor’s degree and relevant experience are essential, preferred qualifications for the Process Development Engineer position at Azzur Group include experience with six sigma methodologies, design of experiments (DOE), and a solid understanding of regulatory requirements related to biopharmaceutical manufacturing.

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Common Interview Questions for Process Development Engineer
Can you describe your experience with protein purification techniques as a Process Development Engineer?

In your response, focus on specific techniques you've employed in past roles, any challenges you overcame, and how your contributions led to improved outcomes. Highlight any relevant data you gathered and how it influenced project decisions.

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What statistical analysis methods do you utilize in process development?

Discuss specific statistical tools you’ve used, such as DOE or Six Sigma methodologies, and explain how these methods helped you to draw conclusions from data and improve processes. Provide examples of how you applied data analysis in past projects.

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How do you prioritize tasks when working on multiple process development projects?

Talk about your organizational skills and any systems you use to prioritize tasks effectively. Mention tools like project management software or methodologies like Agile, and illustrate your approach with examples of past experiences.

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What are some challenges you've faced in process development, and how did you overcome them?

Identify specific challenges related to process improvements or technology integration. Describe your problem-solving approach, the strategies you implemented, and the successes that followed, demonstrating resilience and critical thinking.

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How do you ensure compliance with regulatory standards in your processes?

Explain your familiarity with industry regulations and standards. Provide examples of how you've integrated compliance checks into your processes, ensuring that documentation, procedures, and validations align with regulatory expectations.

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Describe a time when you had to present technical information to stakeholders.

Share an experience where you delivered a presentation. Highlight your preparation process, how you tailored your information for your audience, and the impact of your communication on decision-making or project success.

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What experience do you have with experimental design and trials?

Discuss your background in designing experiments for process trials, including your approach to hypothesis formulation, variable identification, and data interpretation. Mention any successful trials that resulted in significant process improvements.

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Can you explain how you approach teamwork in a lab setting?

Discuss your collaborative skills, emphasizing communication, respect for diverse opinions, and your willingness to support team members. Share specific examples of successful team projects you’ve been involved in and your contributions to team success.

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What tools or software are you proficient in that support your role as a Process Development Engineer?

Outline the specific engineering software tools and Microsoft Office applications you are proficient in, explaining how these tools assist you in modeling data, analyzing results, or managing projects effectively.

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How do you stay current with advancements in biotechnology and pharmaceuticals?

Highlight your commitment to professional development, including attending workshops, conferences, reading industry journals, and engaging with professional networks. Emphasize how this ongoing education informs your work and keeps you innovative.

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Medical Insurance
Dental Insurance
Vision Insurance
Mental Health Resources
Learning & Development
Equity
Paid Holidays
Paid Time-Off
WFH Reimbursements
Child Care stipend
Maternity Leave
Paternity Leave

We will lead the healthcare and life science industries in innovative quality and compliance solutions from Discovery to Delivery™.

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Full-time, remote
DATE POSTED
December 8, 2024

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