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