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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.