Process Technician Aseptic Filling

Manufacturing Process Technician Aseptic Filling

Reporting to the Manufacturing Filling Supervisor, the Manufacturing Filling Process Technician is responsible for the operation, cleaning and upkeep of all equipment and facilities in an aseptic environment in support of manufacturing requirements.

This role is also responsible for the adherence to, and leadership of, all cGMP, training and safety standards for the work area

RESPONSIBILITIES

• 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 an aseptic biologics processing environment for plasma derived pharmaceuticals.
• 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.
• Responsible for the accuracy and completeness of all Company documentation and material reconciliation.
• 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.
• Meeting planning targets and supply chain requirements while improving on work practices, adjusting for multiple changing priorities.
• Making decisions specific to their area of work in a timely manner.
• Ability to utilize MRP systems and complete batch-specific transactions on time.
• Ensure assigned activities as per requirements for a Start Up Project and Commercial facility are completed accurately and in a timely manner
• Performs other duties as assigned, in any area of Grifols World Wide Operations as required by the business.

REQUIREMENTS

• 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 interpersonal skills with the ability to interact with personnel at all levels in a team environment.
• 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.
• Excellent verbal and written communication skills in the English language.
• 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