Process Engineer, Formulation

Process Engineer, Formulation

Location: Columbus, OH

Job Type: Full time

Req : 11071

We are seeking a talented and motivated Process Engineer, Formulation to join our team.

In this role, you will be responsible for supporting the development of pharmaceutical dosage forms and the overall operations for the development team in our Respiratory, Nasal, Semi-Solids & Liquids division including but not limited to the overall production equipment ownership which includes: development, optimization, and control strategy through the various stages of new drug formulation development using an innovative manufacturing technology currently being introduced to the company.

• Lead process design & optimization:
  Responsible for the equipment process design, development and control strategy using a design for manufacturing (DfM) approach to drive defects per million needed to support high quality output.
• Identify and optimize critical process parameters to meet product performance criteria and to create robust processes to drive continuous improvement opportunities.
• Lead planning and execution of activities on the equipment for scale-up, registration and process validation activities for novel drug products. Be the production engineering champion.
• Responsible for gap and risk assessments including statistical data analysis for process scale-up, design and control using appropriate tools e.g. Process Analytical Technologies, Design of Experiments plus statistical modelling tools.
• Collaborate with key internal and external stakeholders to ensure project success including formulation, analytical research, site operations, quality (e.g. equipment validation and quality assurance validation) and technical services to drive successful FAT, SAT, Installation/Operation/Performance Qualification test cases and execution.
• Contribute to regulatory document generation for process related sections of the submission file to support ANDA (505j) and NDA (505(b)(2)) applications.

• B.S in Pharmaceutics, Engineering or other scientific discipline, related to pharmaceutical production equipment.
• Knowledge and understanding of applicable laws and regulations regarding development and manufacturing of pharmaceuticals, including cGMP, DEA, and FDA guidances.
• Knowledge of pharmaceutical production environment with emphasis on scale-up/ optimization and validation.
• Technical knowledge of pharmaceutical processing equipment.
• Knowledge of pharmaceutical formulation development.
• Must possess good written and verbal communication skills.
• Strong problem solving/critical thinking skills — Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
• Strong planning and organizing skills & adaptable to changing priorities.
• A demonstrative ability to manage time-sensitive projects.
• Relevant project management training/certification favorable, but not essential.
• Proficient computer skills with the ability to enter data into and retrieve information from various software programs such as Microsoft Office Suite programs Word, Excel, PowerPoint, Outlook, Access, and internal company software programs such as Labware, SAP, etc. Navigate all applications of software or programs and have trained others how to utilize software.
• Demonstrated teamwork skills - providing information and assistance to supervisors and co-workers in a collaborative manner which encourages trust, mutual respect, and shared purpose among team members independently.
• Critical Thinking skills - Using logic and reasoning to identify the strengths and weaknesses of alternate solutions, conclusions or approaches to problems.
• Independently perform data review and mathematical calculations both written and electronic for accuracy. Ability to troubleshoot and identify out of trend results.
• Equipment experience in several packaging technologies is desired (e.g.: feeders, fillers, themoformers, cartooners, labelers, etc.).
• Equipment experience in several pharmaceutical manufacturing technologies is desired (e.g.: blenders, encapsulators, tablet pressers, granulators, etc.).
• Ability to complete tasks in a…