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Engineer I

Section I:  Job family summary             

Applying engineering principles during process development and scale-up activities.  Study and implement optimum and well controlled manufacturing process(s).  Provide key input in determining important process variables and development of robust process.  Evaluate, select and order equipment that is appropriate and cost effective for the manufacture of product(s).  Oversee the installation, modification, upgrade and maintenance of manufacturing equipment.  Study equipment performance and reliability.  .

Section II:  Essential duties and key job responsibilities and essential functions.

  • Proposes design and performs various engineering studies aimed at process development, optimization, scale-up and technology transfer for the efficient manufacture of new or existing drug products.
  • Prepares protocols and summary reports for process development research studies and batch manufacturing campaigns.  Collaborates with Clinical Manufacturing, Formulation Development, QA/QC, Validations and Facilities Engineering to organize activities associated with protocol execution.  May supervise technical staff during execution of experimental studies.
  • Propose new solutions for process and equipment selection.
  • Aid in PAT implementation for manufacturing.
  • Responsible for observing all Company, Health, Safety and Environmental guidelines.
  • Duties and responsibilities are not limited to above and may include other assignments as necessary.

(Where reference is made to regulatory environment requirements and/or compliance this includes all applicable regulations i.e. FDA, ISO 13485/9001, European requirements, etc.)

Section III:  Minimum qualifications to perform the job; specific skills, education, knowledge and job experience necessary to perform essential duties; physical requirements for job if any.

  • BS Degree in engineering or a similar technical  disciplines (e.g., pharmacy, chemistry) with 7-10 years of relevant experience or MS Degree with 5-7 years relevant experience or equivalent combination of education and experience.
  • Working knowledge of manufacturing processes, validation principles, quality systems, engineering design fundamentals, regulatory expectations and industry trends.
  • Working knowledge of 21 CFR 200 series cGMP’s.
  • Strong technical writing, verbal communication, interpersonal and problem solving skills.
  • Determine methods and procedures on new assignments and may provide guidance to others.
  • Experience remediating protocol exceptions.
  • Computer Skills – Microsoft Word®, Excel, Visio, and PowerPoint.
  • Pharmaceutical process or research product development preferred.

Engineer II

Applies engineering principles during process development and scale-up activities.  Study and implement optimum and well controlled manufacturing process.  Provide input in determining important process variables and development of robust process.  Evaluates, selects and orders equipment that is most appropriate and cost effective for the manufacture of products.  Oversee the installation, modification, upgrade and maintenance of manufacturing equipment.  Studies equipment performance and reliability.  Defines and write preventative maintenance schedules.

Section II:  Essential duties and key job responsibilities and essential functions.

Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.  May determine methods and procedures on new assignments and may provide guidance to others.

  • Proposes design and performs various engineering studies aimed at process development, optimization, scale-up and technology transfer for the efficient commercial manufacture of a new drug product.
  • Prepares protocols and summary reports for process development research studies and batch manufacturing campaigns.  Collaborates with Clinical Manufacturing, Formulation Development, QA/QC, Validations and Facilities Engineering to organize activities associated with protocol execution.  May supervise technical staff during execution of experimental studies.
  • Propose new solutions for process and equipment selection.
  • Aid in PAT implementation for commercial manufacturing.
  • Responsible for observing all Company, Health, Safety and Environmental guidelines.

Duties and responsibilities are not limited to above and may include other assignments as necessary.

Section III:  Minimum qualifications to perform the job; specific skills, education, knowledge and job experience necessary to perform essential duties; physical requirements for job if any.

  • BS/BA Degree in engineering or a related discipline with 6-8 years of experience or MS/MBA with 4-6 years related experience or an equivalent combination of training and experience.
  • Working knowledge of manufacturing processes, validation principles, quality systems, engineering design fundamentals, regulatory expectations and industry trends.
  • In depth knowledge of high shear mixing, Tangential Flow Filtration and Lyophilization is strongly preferred.
  • Working knowledge of 21 CFR 200 series cGMP’s.

Memorial to Andy Soos

It is with great sadness that the NJAIChE recognizes the passing of one of its giants: Andy Soos. Andy served NJAIChE in each of five decades. He had multiple terms as Chair and Secretary and volunteered his time, expertise, and energy in many other important functions. His sense of humor was quick and dry as he brought light to everything we did. His talent for travelogues and newsletters was legendary. Andy was recognized at the national level as a Fellow of the American Institute of Chemical Engineers.

A 1972 graduate of the New Jersey Institute of Technology, Andy served in many positions where his expertise in safety and environmental regulations was prized. He mentored many students and other professionals, always encouraging them to excellence in engineering and the highest standards of integrity. Andy retired in 2018 yet still wrote newsletters and attended the 2019 NJAIChE Holiday Party.

Below are pictures of Andy lecturing on stress management, and on one of his exciting vacations with his wife Elise.

Our sympathy and prayers go out to Andy’s family and all who knew and will miss him. Rest easy Andy.

More information on Andy’s death and life can be found at these links:

Andrew (Andy) D. Soos

http://buelermortuary.com/category/obituaries/

Sept. 17 4:00 PM online: Pharmaceutical Quality

From our friends at NJPhAST:

Managing Pharmaceutical Quality:

In And Beyond the

COVID-19 Pandemic

register at WWW.NJPhAST.org

Ajaz S. Hussain, Ph.D.
(The National Institute for Pharmaceutical Technology and Education, Inc. )

The supply of pharmaceuticals to patients have been on a critical path for decades. Now, this path is more tortuous. Reshoring of the pharmaceutical supply chain is emerging as a vital national security need. Re-shoring traditional know-how and technologies with inherent unpredictability and adverse environmental impact are unlikely to provide security sought, nor will it be competitive and affordable. The challenge is complex and in chaos, akin to reforming professionals and systems1. Are the calls and funding to re-shore sustainable? What “new prior knowledge”2 is needed? How can we transform and mature systems for quality management? Why “chaos to continual improvement”3 charts this journey?

1 Gurvich, V.J., Hussain, A.S. AAPS PharmSciTech 21, 153 (2020). https://doi.org/10.1208/s12249-020-01718-9

2 Hussain, A.S., Gurvich, V.J., and Morris, K. AAPS Pharm Sci Tech, 20, 140 (2019). https://doi.org/10.1208/s12249-019-1347-6

3 Hussain, A.S. Chaos to Continual Improvement: Path to Harmonization. CPhI Industry Report 2019: https://www.cphi.com/content/dam/Informa/cphi/en/cphi-insights/HLN19-CPhI%20Insights-2019-Industry-Report.pdf

Date and Location
Thurs Sept 17th, 2020
4:00 – 5:00 PM


Meeting Sponsors:
BioDuro
Gattefossé
Natoli
Online Meeting
LINK TO BE PROVIDED

About the speaker Dr. Ajaz Hussain holds B.Pharm and Ph.D. degrees from the universities of Mumbai and Cincinnati, respectively, his 30 plus years of unique experience covers academia, the US FDA and industry (Deputy Director, Office of Pharmaceutical Science, US FDA, VP and Global Head Biopharmaceutical Development at Sandoz, Chief Scientific Officer at Philip Morris International and Chief Scientific Officer and President Biotechnology at Wockhardt. Currently, he devotes part of his time to serve as the President of the not-for-profit National Institute for Pharmaceutical Technology and Education. In his advisory practice, he focuses on developing corporations and individual professionals as self-authored architects of evidence they need to make sound decisions efficiently. Typically, he engages with life science companies on challenging problems in product development, manufacturing, quality control, and assurance functions. He is also a member of several Boards, and he also serves as an Adjunct Professor at Long Island University

Registration Fees • Please register at http://www.njphast.org in order to be sent the meeting link; this will be sent out closer to the date of the meeting. • There is no registration fee for this event. • Note that even though no payment is needed, you must proceed all the way to the “Your Order is Confirmed” message for your registration to be recorded. • You will need to make a “Regular” or “Vegetarian” meal selection, but note that we will not be delivering food !