Provides first-line supervision of the plant and is fully competent in all relevant operational, start-up, cleaning, and checking procedures associated with the operation of at least one plant, ensuring high-quality output in a safe and effective manner. This includes monitoring and controlling the work activities of the team in a given area of the plant and escalating issues effectively to the Team Leader or Management.
Expert in Group 1 process, with experience in at least three Group 2 and Group 3 processes within the core area of work.
Supports and leads RCF and CANDO activities in conjunction with the Team Leader.
Trained in Ensur, Workmate, Trackwise, SAP, and Open Options, capable of seamlessly covering for the Team Leader.
Flexibility to work across API Plants as required to support the business.
Competencies
* Investigates and reports problems on equipment, organizing maintenance through direct interaction with engineers or escalation to the Team Leader or management.
* Competent in writing permits and conducting risk assessments up to Hot work permit level.
* Understands RCF investigation processes and can lead thorough investigations into incidents or issues, documenting accurately on Batch documentation and adding detailed SI comments as needed.
* Proactively works with the Team Leader to meet training targets and supports the training of team members through coaching, training, and supervision.
* Maintains high awareness of safety and hazards in the API facility, identifying safety-critical issues and taking appropriate actions to rectify or escalate. Coaches team members in hazard identification.
* Leads CANDO activities and monitors housekeeping and plant standards to ensure operations are at standard at all times.
Key Responsibilities
* Competent in completing and reviewing batch documentation, equipment logs, and computer transactions related to the process.
* Monitors and records all actions to the highest DI standards.
* Ensures the quality of work aligns with GMP requirements.
* Issues permits up to hot work level.
* Supervises plant operations in the absence of the Team Leader, capable of covering the Team Leader seamlessly.
* Raises REWs and DRs as required, and updates SOPs/SOIs.
* Participates in new product introductions, liaising with other departments early in the process.
* Works under some supervision, taking ownership and escalating issues when support is needed.
* Manufactures a variety of products according to SOPs.
* Operates at least one plant proficiently and has significant knowledge of another.
* Selects and dispenses materials, loads equipment, and makes process adjustments as necessary.
* Performs minor maintenance to minimize downtime, following permits and procedures.
* Performs cleaning and washing of equipment following established procedures.
* Leads and drives process improvements with measurable benefits.
* Investigates and reports equipment problems and organizes maintenance.
* Responsible for production and related paperwork and data entry.
Qualifications
Essential
* Ability to coach and train operators in process operations.
* Deep experience in API operations and plant systems, with expertise in API processing in their area.
* Ability to investigate and document process, Quality, or ESH issues.
* Understanding and competence in RCF methodologies.
Relevant Experience
* Practical knowledge of the process for effective problem resolution of production issues.
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