Reporting to the Shift Supervisor, the successful candidate is responsible for the operation, cleaning and upkeep of all equipment and facilities in a cleanroom environment in support of manufacturing requirements.
Responsible for the adherence to, and ownership of, all cGMP, training and safety standards for their work area.
Key Responsibilities
*Assist with the creation and maintenance of area SOPs and validation documents for equipment and procedures, and assist in the writing of area status reports, regulatory documents, and process descriptions.
*Ensure safe and timely completion of all process activities according to cGMP's.
*Adhere to procedures and practices and maintain compliance with applicable departmental, corporate, industrial, health & safety and regulatory requirements.
*Ensuring that the gowning philosophies for all cleanroom, production and facility areas are strictly adhered to and all non-conformances are immediately actioned and reported.
*Ownership for the setup, coordination, regulation and troubleshooting of processing equipment in all cleanroom environments
*Responsible for the cleaning (Manual and automated CIP/SIP) and upkeep of all associated facilities and equipment and for ensuring all areas are maintained in proper working order.
*Maintain a safe and clean work environment by following current good manufacturing practices (cGMP), and standard operating procedures; complying with legal regulations; monitoring environment.
*Ability to operate automated scada-controlled/windows-based control systems in a GMP environment.
*Recommend and implement measures to improve production methods, equipment performance, facility layout, and quality of product. Actively participate in the company's Continuous Improvement programs.
*Co-operate and support quality investigations and contribute to CAPA reporting and closure.
*Provide guidance and hands-on training to peers and colleagues and ensure all training records are up to date and in line with training SOP's, OJT's and policies.
*Capable of maintaining production without supervision, anticipates and adjusts for interventions, effectively manages multiple priorities
*Performs other duties as assigned by Manufacturing Supervisors to meet the needs of the business
*Making decisions specific to their area of work in a timely manner.
Education/Experience
To be successful in this role you will require:
*Prior relevant experience in a regulated manufacturing operations environment.
*Working knowledge of production operations, scheduling, design, planning, etc.
*Knowledge of lean management systems.
*Previous experience defining and establishing policies and SOPs.
*Excellent communication, and interpersonal skills.
*An ability to work independently and as a member of a team in a dynamic, fast-paced and goal driven environment.
*Must be proactive, results oriented, and have strong attention to detail.
*Self-starter with strong work ethic and the ability to exercise good judgment.
*Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines.
*Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis.
*Demonstrated ability to inspire high performance in self and others and support team members around shared goals.
*Comprehensive knowledge and understanding of cGMPs, EU regulations, and industry guidelines highly preferred.
*Must be available to work shift as directed by the organization.
*Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint
*Bachelor's degree preferred: Emphasis on Biology, Chemistry, Manufacturing or Mechanical Engineering or closely related scientific / technical discipline desired. Equivalency: In lieu of a bachelor's degree, candidates must have a minimum of 2 years of related experience in a pharmaceutical, GMP, or EU regulated environment
