Purpose of the role: Reporting to the Engineering/Facilities Manager, this position is primarily responsible for the state of quality validation for the equipment, facility, processes and cleaning validation at the Le Sueur manufacturing facility. Key
Role Specific Requirements:
- 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.
- Provides validation support to Regulatory Affairs Department for product submissions and regulatory filings.
- Remain current on legislative, regulatory, and technical changes within the industry, and on training requirements within the facility. Continually develops expertise and acts as a technical expert for the various validation and production activities.
- 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 Le Sueur facility.
- Assign equipment asset number to new equipment and manage calibration, verification, and maintenance records for the new equipment.
- Performs regular validation and performance qualification audits as necessary to ensure conformity to all regulatory requirements. Identifies areas of validation failure or deviations from established process and product standards, providing recommendation to solve identified problems.
- Participates in regulatory audits by government regulatory agencies and audits by customers.
- Conducts validation reviews as needed for the facility’s change control process, deviation process and batch records.
- Create and validate batch record calculations sheets as required.
- Create and maintain drawings and diagrams for regulatory agencies and in plant use.
- Support the management in equipment selection and facility modifications. This includes preparing or supporting URS, researching equipment options, obtaining equipment quotations, assisting in preparing capital equipment expense requests, and ensuring equipment is delivered as specified in the URS.
- Support the North American EHS Manager and other management in environmental activities as required. This includes assisting in the maintenance of the storm water pollution prevention plan, providing storm water training as needed, and assisting in TRI and wastewater compliance.
- Support Hoshin teams and A-3 activities.
Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.
Competencies Required for the Role
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.
Other Requirements Essential:
- 4 years relevant experience, preferably in a regulated pharmaceutical industry with 2 years in a validation role. (Medical device and food industry also considered)
- Bachelor 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.
- 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
- Master’s degree in science or related field
- Blue Mountain calibration and asset management system experience
About Bimeda: Bimeda is a leading global innovator, manufacturer and marketer of 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.
Bimeda’s global innovation program sees eight state-of-the art R&D centers across four continents collaborate on an enviable product development pipeline which anticipates the ever-evolving needs of the animal health industry.
Bimeda’s eleven manufacturing facilities across eight countries allow the company to manufacture a broad range of preventative, curative and nutritional products including sterile injectables, vaccinations, nutritional boluses, feed additives, tablets, water-soluble powders, pastes and non-sterile liquids.
Globally, the company focuses on the development, manufacture and commercialization of quality Bimeda-branded products while also being the partner of choice for contract manufacturing and R&D services for prominent companies within the animal health industry.