Scismic is supporting a leading manufacturing company that market and manufacture veterinary pharmaceuticals and animal health products and has over half a century’s experience in providing science-driven solutions to optimize the health, wellbeing and productivity of the world’s animals.

Role Summary:

Reporting to the Plant Manager, this position is primarily responsible for the state of validation for the equipment, facility, processes and cleaning in the Le Sueur, Manufacturing Facility.

Key Responsibilities:

• Review, plan, schedule and organize validation projects for new and existing areas, including manufacturing equipment, processes, plant systems, storage facilities and equipment.
• Develop and implement all necessary standard operating procedures for validation of plant processes, equipment installation and operational qualification (IQ/OQ), performance qualification (PQ), requalification and revalidation of critical systems and utilities.
• Design IQ/OQ/PQ and validation campaigns, develop, prepare and write the protocols for process validation, equipment validation, cleaning validation, IQ/OQ and performance qualification.
• Coordinate validation and IQ/OQ/PQ activities with production, quality control laboratories and outside contractors providing leadership, training and guidance.
• Review and analyze moderately complex analytical and physical data generated from validation activities. Write validation final reports that present, summarize and offer conclusions on the validity of the process based on the results of the analysis and obtain necessary approvals on a timely basis.
• Coordinate the facility qualification program by preparing the protocols, monitoring the execution, auditing the results, and assisting production in resolving any identified problems.
• Recommends validation approaches / strategies, priorities, and resources required. Accountable for accuracy and integrity of protocols, reports and documentation generated to meet regulatory authorities, accountable for meeting critical deadlines for complex projects.
• Schedule and coordinate calibration events. Log and maintain calibration certificates and records both hard copies and operation of the Blue Mountain RAM program in the Irwindale facility.
• Assess proper functionality of the Getinge Sterilizer by performing weekly autoclave cycles.

Essential Requirement:

• 7 years relevant experience in a regulated pharmaceutical industry with 5 years in a validation role.
• Bachelors of Science in science or related field.
• Knowledge of validation strategies and execution techniques, validation requirements and regulatory expectations for GMP compliance.
• Familiarity with maintenance processes, PM management and general equipment operations.
• Experience and knowledge of Kaye validator.
• Must possess strong customer focus and quality mind set.
• Is a champion of compliance while balancing business results.
• Strong command of the English language; written and orally.

Desirable Requirement:

• Masters Degree in science or related field.
• Blue Mountain calibration and asset management system experience.

Competencies:

Critical Thinking – Is the ability to be thoughtful and draw pertinent conclusions after a discussion or meeting; can eventually support the final outcomes and decisions.

Effective Communication - Is the ability to convey information to another effectively and efficiently, to listen – help facilitate sharing of information between people. It is about understanding the emotional intention behind the information. The ability to express oneself clearly in conversations, confirm understanding, communicate using data and facts whilst adapting to one’s audience. Exhibit willingness to listen, and show respect for oneself and others in interactions with others. Express oneself clearly in verbal and business writing

Thoroughness/Detail Oriented – Ensuring that one’s own and others’ work and information are complete and accurate; carefully preparing for meetings and presentations following up with others to ensure that agreements and commitments have been fulfilled.

Planning – Is the process of thinking about and organizing the activities required to achieve a desired goal.