The Manufacturing Technician II reports to a Manager/Supervisor in the Inspection Process Execution Team (PET) operations. This position will require working in variousControlled/Non-Classifiedareas. The Technician performs a variety of manufacturing tasks (operates equipment, performs visual, cosmetic, and physical inspection, line clearances, OEE data collection and completes batch record entries) and supports improvement activities (5S, participate in problem-solving and Kaizen events, manual data collection) in accordance with cGMPs.

Primary Responsibilities

• Perform the duties of operating assigned machinery consisting of servicing automated inspection equipment, monitoring equipment status, reintroduction of materials, manually palletizing inspected materials, and assuring a smooth flow of product.
• Perform manual visual, cosmetic, and physical inspection of material. Promptly escalate concerns to Lead and Manager/Supervisor as needed.Must obtain and maintain visual inspection qualification.
• Be able to start up equipment, make minor adjustments to machinery, remove jams, minor troubleshooting, and minor assembly/disassembly for cleaning purpose.
• Ability to use material handling equipment such as motorized and manual pallet jacks, non-motorized lifts.
• Perform cleaning, housekeeping and line clearance activities for assigned areas as required to maintain a cGMP environment.
• Perform batch record and GMP documentation entries. Maintain records and/or logs as required in the performance of job responsibilities. This will include mathematical computation where needed.
• Knowledge of product security controls and material handling equipment.
• Responsible for outgoing quality level.
• Be familiar with job-related safety procedures and hazards including PPEs, ergonomics, LOTO, human safety, material handling, waste handling, chemical handling, and spill controls. Report all discrepancies to process facilitator.
• Perform work requirements in a responsible manner, in accordance with SOPs, cGMPs and established safety procedures in accordance with OSHA requirements and guidelines. Be familiar with "Material Safety Data Sheets" for area chemicals.
• Obtain knowledge to be able to print off SOP's/Forms via ECMS.

Other Responsibilities

• Support lean activities and process improvement work such as performing 5S in the work area, participating in problem-solving, and manual tracking of performance data for OEE and process improvement analysis.
• Review process documents such as operational SOPs, forms and batch records for accuracy. Identify and provide suggestions for process improvement while maintaining quality and cGMP compliance as opportunities arise.
• Be flexible and support other work areas as needed
• Perform all other assigned duties with minimal supervision under the direction of the process facilitator or designee as needed.

Optional Training / Responsibilities

• Obtain cold room training/access to be able to transfer materials in and out of the cold rooms.
• Take proper training to become certified trainer on assigned equipment and process tasks. Train and conduct evaluations on other team members for training qualifications.
• Obtain a novice to intermediate level of knowledge of SAP inventory movements and inventory management such as moving items from one storage location to another and goods issuing items to process orders as required.

Competencies & Job Requirements:

• Acquire and maintain all required certifications and qualifications for the assigned work area
• Capable and motivated to learn new skills and develop new capabilities on an on-going basis to contribute to the success of the Process Execution Team
• Ability to work effectively in a team environment
• Candidate should possess the ability to work in and adapt to a changing/demanding environment
• Some overtime may be required with minimal advance notice to support business needs

Minimum Qualifications:

• Experience in a pharmaceutical or cGMP regulated environment
• Must have the ability to effectively understand, read, write, communicate and follow instructions in the English language.
• Good attention to detail is required. Individual must be capable of keeping accurate records and performing mathematical calculations.

Preferred Qualifications:

• Prior production experience
• Experience working in a LEAN manufacturing environment
• Knowledge of cGMPs and FDA policies/procedures
• Prior inspection experience in a pharmaceutical manufacturing environment.