Interested in this position. Reach out to us using the Contact NJAIChE page.

Engineer III

Section I:  Job family summary   

The Facilities Engineer is responsible for ensuring that all building systems, particularly HVAC, Purified Water and Utility systems are designed, installed, commissioned, maintained and operated in accordance with the company’s  requirements.  Particular emphasis will be on larger capital projects and new equipment installations.  The Facilities Engineer III is responsible for tuning building systems to operate as efficiently as possible as well as identifying and implementing building system upgrades.  Incumbent often engages outside service providers to complete tasks and therefore is required to manage the resources, define requirements and review results.  Incumbent will be responsible for setting and executing long term capital strategy and budgets, identifying and running capital projects, defining scope and capital cost as well as writing and executing Capital Authorization Requests.   

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

  Identify, initiate, and execute projects that improve the facility or manufacturing processes, provide greater functionality, add new capabilities, or correct deficiencies

• Take ownership of the capital plan for Facilities, set and maintain the capital budget and forecast, and take the leadership role in running the projects within the plan
• Provide technical assessments, conceptual designs and outline specifications
• Responsible for ensuring that all critical building utility systems are operating efficiently and that the HVAC and purified water systems are in GMP compliance and in a qualified state.
• Work with facility mechanics to monitor and maintain building systems
• Work individually or within an engineering team to proactively identify building system deficiencies and opportunities for improvement
• Work cooperatively with outside engineering and construction firms to establish/communicate project timelines and milestones and drive projects to meet them
• Manage and access detailed drawings
• Complete necessary documentation such as opening deviations, performing investigations, writing change controls and writing SOP’s
• Recommend, design,  prepare cost justification, purchase and install equipment and systems to meet objectives
• Supervise activity of consultants, outside engineering firms, vendors and contractors, assuring safe and proper installations to protect facility assets
• Ensure that drawings and Engineering Turnover Packages (ETOPs) are provided for all projects, and maintain the Engineering Documentation Library
• Ensure projects comply with OSHA, EPA, CT DEEP and other governmental requirements
• Responsible for observing all Company, Health, Safety and Environmental guidelines.

Duties and responsibilities are not limited to the work listed above and may include other assignments

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.

• Minimum BS degree in Chemical or Mechanical Engineering
• 7-10+ years of experience in design, installation and balancing of HVAC and mechanical systems for pharmaceutical manufacturers
• Detailed knowledge of the design, operation and qualification of purified water systems
• Experience with building systems and equipment including electrical, compressed air, water, HVAC, and waste systems
• Experience managing small and large facility installation and upgrade projects from inception to completion
• Working knowledge of current Good Manufacturing Practices
• Demonstrated excellent written and oral communication skills
• Strong interpersonal skills

Interested in the positions below? Let us know using the Contact NJAIChE page.

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.

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/