Primary Responsibilities: • Plan, organize and oversee all activities related to the manufacturing and packaging of MDIs to include batch planning, operations, troubleshooting and shift personnel management. • Review and compile the documents generated during the production of MDIs such as batch records and protocols (i.e. validation protocols, qualification protocols, etc.). • Ensure and compliance with safety, quality, productivity, and performance expectations and execution of manufacturing and packaging operations. • Evaluates various stations of the production operation to ensure optimum efficiency and follow through. • Initiate and review written procedures such as standard operating procedures (SOPs), operating instructions, cleaning procedures, safety procedures, and other work procedures as needed. • Work with Integrated Product Development (IPD)/R&D on the execution of bio-batches (abbreviated new drug applications - ANDA) and validation batches. • Coordinate with departments such as Quality Assurance (QA), Quality Control (QC), Research & Development (R&D), Maintenance & Engineering, Supply Chain and Warehousing, Human Resources, and other internal functional partners with respective to the completion of quality work and achieving the production schedules and performance objectives. • Ensure the process flow of raw materials, supplies, and other resources. • Provide daily supervision and support to operators in daily production activities such as trouble shooting and other work tasks. • Follow production schedules, ensures quality standards, and handle technical and administrative issues on assigned shift. • Maintain communication between employees and upper management to ensure procedures and policies are understood. • Assist with recruiting, hiring, training, motivating, and evaluating the performance of a diverse manufacturing team. • Manage performance and train assigned employees using Company systems, procedures, policies, practices, and other tools to meet established performance standards, productivity targets, and overall business requirements. • Produces requirements by operating and monitoring equipment; observing varying conditions; adjusting equipment controls; calculating concentrations, dilutions, and yields; adhering to aseptic filtering and filing procedures. • Keeps equipment operating by following operating instructions; troubleshooting breakdowns; calling for repairs. • Documents production by completing forms, reports, logs, and records of equipment and batches. • Update job knowledge by participating in training opportunities. • Maintain accurate and clear documentation that proves that manufacturing is being carried out in accordance with both internal and external quality systems or regulations. • Keep maintenance logs for all of the machines or processes they oversee, which requires proficiency in word processing and spreadsheet software. • Follow strict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Manufacturing Practices (cGMP), complying with legal regulations, monitoring environment. • Other duties as assigned. Education and Experience: • Bachelors degree in Pharmaceutical engineering, Pharmaceutical Sciences or related field of study from an accredited college/university required. • Masters degree in Pharmaceutical Engineering, Pharmaceutical Sciences, or related field of study from an accredited college/university preferred. • 1-3 years of direct work experience in pharmaceutical manufacturing. • Technical Knowledge and Computer Systems Skills • Understanding of machines used in pharmaceutical manufacturing. • Capable of conducting troubleshooting, investigations and root cause identification and analysis. • Capable of handling and participating in compliance and regulatory audits at the local and federal levels. • Must be proficient in computer skills and software applications such as Microsoft Office tools. • Experience using SAP business system and applications is a plus. • Experience in Inhalation products (MDI) is a plus. • Professional and Behavioral Competencies • Proficiently speak English as a first or second language • Ability to understand and analyze complex data sets. • Knowledge of statistical packages is a plus. • Knowledge of good manufacturing practices and good documentation practices preferred. • Ability to read, write and communicate effectively. • Self-motivated, with the ability to work in a fast-paced manufacturing environment and handle multiple tasks simultaneously. • Excellent organizational skills with the ability to focus on details. • Basic computer skills (Word and Excel) Intermediate • Good basic math knowledge and excellent attention to details. • Work Schedule and Other Position Information: • Must be willing to work in a pharmaceutical manufacturing setting. • Must be willing and able to work any assigned shift ranging from first, second, or third shift. • Work schedule may be Monday to Friday, Tuesday to Saturday, or some combination thereof based on business needs. • Must be willing to work some weekends based on business needs as required by management. • Relocation negotiable. • No remote work available. • No employment sponsorship or work visas.