Senior Process Operator
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Job Description
Job Overview
Provides first line supervision of the plant and is fully competent on all relevant operation, start-up, cleaning and checking procedures associated with the operation of at least one plant, ensuring a high quality output is achieved in a safe and effective manner. This includes monitoring and controlling the work activities of the team in a given area of plant and escalating issues effectively to Team leader or Managment
Expert in Group 1 process, at least three Group 2 and Group 3 processes in core area of work.
Subject matter expert supporting and leading RCF and CANDO activities in conjunction with Team Leader.
Trained in Ensur, Workmate, Trackwise, SAP and Open Options. Capable of seamlessly covering for Team Leader.
Flexibility to work across API Plants as required to support to the business.
Competencies
• Investigates and reports problems on equipment and organises maintenance through direct interaction with engineers, and through escalation to Team leader or directly to management
• Competent to write permits and carry out risk assessments up to Hot work permit.
• Understands RCF investigation process and can lead thorough and timely investigation into any incident or issue on shift. Accurately documents issues on Batch documentation and can add accurate and detailed SI comments as required
• Understands their training targets and responsibilities and is proactively working with TL in execution of their training plan. Supports training plan of team members in their area through coaching, training and supervision of processing activities of trainees
• Has a high awareness of Safety and of the identified hazards in the API facility. Is able to identify safety critical issues and understands the correct actions to rectify or escalate as appropriate. Coaches and works with team in their area to build their skills in hazard identification.
• Leads CANDO activity in their area and monitors housekeeping and plant standards in their area of operation ensuring operation is at standard at all times.
Key Responsibilities
• Fully competent in the completion and review of all batch related documentation, equipment / area log books, and computer transactions associated with the process.
• Will monitor and record all actions to the highest DI standards
• Responsible for the quality of work as all work is subject to GMP
• Issuance of permits up to hot work level
• Supervision of plant in absence of team leader (Trained in Ensur, Workmate, Trackwise, SAP and Open Options. Capable of seamlessly covering for Team Leader). First point of contact for operators on all production matters.
• Raises REW's and DR's as required. Progresses SOP / SOI updates
• Takes on a key role in new product introduction, liasing with other departments and getting involved at early stage of process.
• Works under some direct supervision but takes ownership and escalates issues if support is required
• Will manufacture a wide variety of products according to SOP's
• Fully competent in the operation of at least one plant, and have significant knowledge of operations in at least one other.
• Selects and dispenses required material, loads equipment, making adjustments to process as necessary
• May carry out minor maintenance work to minimise down time, e.g., tighten flanges, change pressure gauges, replace pH probes, etc. This must be done fully following permit or written risk assessment and ensuring all procedures are followed.
• Required to clean and wash equipment following established procedures
• Leads and drives improvements with measurable benefits
• Investigates and reports problems on equipment and organises maintenance.
• Has responsibility for production and all associated paperwork and computer data entry
Demonstrates leadership skills
Qualifications
Essential Qualifications
• Able to coach and train operators in process operations
• Wide and deep experience of API operations and of plant systems. Expert in API processing in their area of operation.
• Able to investigate and document any process, Quality, or ESH issue identified in their area.
• Understands and is competent in RCF methodologies.
Relevant Experience
• Possesses practical knowledge of the process; which allows for effective problem resolution of production issues.
About Us
In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.
Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.
Equal employment opportunity
Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.
We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.
About the Team
Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited's investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.