Process Engineer, Formulation

Process Engineer, Formulation Location: Columbus, OH Job Type: Full time Req ID: 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. Key Responsibilities 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. Qualifications 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 timely manner with minimal supervision. Seeks efficiency in planning workload and looks for opportunities to maximize output. Experience in working to cGMP and compliance requirements is desirable but not essential. Position may involve travel (about 10%) to different countries to evaluate / qualify new equipment / technology as needed. Preferred Qualifications Proficient knowledge and understanding of applicable laws and regulations regarding development and manufacturing of pharmaceuticals, including cGMP, DEA, and FDA guidances. Demonstrated knowledge of pharmaceutical production environment with emphasis on scale-up / optimization and validation. Demonstrated technical knowledge of pharmaceutical processing equipment. Knowledge of pharmaceutical formulation development. What We Offer Annual performance bonus, commission, and share potential Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 4% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries 3 personal days (prorated based on hire date) 11 company paid holidays Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits Employee discount program Wellbeing rewards program Safety and Quality is a top organizational priority Career advancement and growth opportunities Tuition reimbursement Paid maternity and parental leave *Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Equal Opportunity Employer Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law. #J-18808-Ljbffr Hikma Pharmaceuticals