Manufacturing Supervisor – Langhorne, PA

Responsible for ensuring that all manufacturing machinery and equipment’s is manned with properly trained personnel to ensure that the production schedule is executed. Ensure that the manufacturing batch records are filled out as per the appropriate Standard Operating Procedures (SOPs).

Key Duties and Responsibilities

• Preparation of Standard Operating Procedures, revision of SOP’s
• Ensuring the Batch records, Standard operating procedures and validation protocols
• Initiation and Implementation of Change controls
• Comply with cleaning and sanitization of manufacturing area including equipment, walls, floors and ceilings per procedure
• Ensure the assembling or set-up of process equipment’s or machines
• Preparation of User Requirement Specifications for equipment
• Actively involved in Batch manufacturing and process validations
• Preparation of Validation protocols for equipment and executing the protocols
• Review of Executed documents, log books, Protocols and batch records
• Conducting the training for batch records, standard operating procedures and validation protocols
• Interacting with cross functional team personnel to attain the flow of activities with compliance
• Involved in preparation, participation of aseptic process simulation (media fill) activities and media fill planner according to respective protocol
• Involvement in planning of production activity based upon API, packing and raw material availability, personnel availability and customer requirements
• Involvement in performance verification of major processing equipment
• Report accidents, unsafe conditions or unusual circumstances to supervisor
• Comply with FDA guidelines/Company Policies of Data Integrity
• Understand and adhere to all cGMP and FDA regulations
• Execution/ coordination of validation protocol testing
• Other duties as required or delegated

Supervisory Responsibilities:

• Supervise the daily actives and tasks to be performed to support the batch production
• Become the SME for the manufacturing process and equipment
• Write and modify SOPs for the manufacturing process
• Train operators
• Work with scheduling and warehouse to assure we setup for production schedule
• Assist with the writing of deviations/investigations and change controls

Education and Experience:

• Bachelor’s degree in chemistry or scientific discipline preferred
• Previous sterile aseptic experience is required
• 3 years of previous pharmaceutical experience and at least 1 year of technical writing experience
• Continuous working knowledge of applicable FDA/ICH/DEA regulations, and cGMP guidelines