Jobbörse

Fall River, MA, United States

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 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.