Validation Specialist

1 week ago

Le Sueur, United States Bimeda Full time
Job DescriptionJob DescriptionSalary:

Purpose of the Position/Role Summary

The Validation Specialist reports to the Validation Manager. The specialist initiates and executes validation studies

throughout the facility.


Role Specific Requirements:

 

  • Interact with all levels of management and staff to manage and facilitate the validation process from inception to completion by enlisting cooperation, support and approval for identified validation projects 
  • Plan, schedule and organize validation projects for new and existing areas, including manufacturing processes, plant systems, cleaning and equipment.  Prepare project plans.  Identify necessary internal and external resources for completion of validation projects and secure the necessary support (Production, Maintenance, QC, QA, outside contractors). Interface extensively with the QC/QA, Production and Maintenance departments to identify projects and problems requiring validation support.  Plan and assign priorities to ensure critical projects meet required deadlines. Work with Regulatory Affairs Dept. to provide validation support for regulatory submissions 
  • Develop and implement all necessary standard operating procedures for validation of plant processes, equipment installation and operational qualification (IQ/OQ), performance qualification (PQ), and requalification of critical systems, utilities and production processes 
  • Design IQ/OQ/PQ and validation campaigns, develop, prepare and write the protocols for process 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.   Monitor and support the execution of the protocols through training, facilitating, and problem-solving activities.  Assure appropriate testing, and support methods validations are completed through extensive interaction with quality control and R&D 
  • 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 
  • Coordinate the facility qualification program by preparing the protocols, monitoring the execution, auditing the results, and assisting production in resolving any identified problems 
  • Recommend validation strategies, priorities, and resources. Accountable for accuracy and integrity of protocols, reports and documentation generated to meet regulatory authorities, accountable for meeting critical deadlines for complex projects 
  • Any other duties as assigned 

 

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 Requires for the Role:


PROCESS IMPROVEMENT – involves the business practice of identifying, analyzing, and improving existing processes to optimize performance. 

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

FOSTERING COLLABORATION/TEAMWORK- is the ability to work jointly with others or together especially in an intellectual endeavor; the ability and desire to work cooperatively with others on a team; as a team leader, the ability to demonstrate interest, skill, and success in getting groups to learn to work together. Builds partnerships for global performance.  Respects others. 

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.  Exhibit willingness to listen, and show respect for oneself and others in interactions with others.   express oneself clearly in verbal and business writing. 

RESULTS ORIENTATION – The ability to focus on the desired result of one’s own department’s work, setting challenging goals, focusing on the goals, and meeting or exceeding them. 


Other Requirements

  • Must have a minimum of 1 year of experience updating GMP relevant documentation in a Pharmaceutical environment 
  • Bachelor’s degree in science or Engineering 
  • Strong interpersonal, written, oral, communication, organizational and planning skills 
  • Strong knowledge of personal computer systems and desktop office applications 
  • Sound understanding of scientific principles communication and project management skills 
  • Willingness to work off hours e.g. after hours, weekends etc. whenever access that is not disruptive to production is required or given. 


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 six 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 nine manufacturing facilities across seven 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. 
 
Your application to us; assumes you have read and agree with our privacy policy  
 
More Info at www.bimedacareers.com 

  • Facilities Maintenance Specialist

    1 week ago

    Le Mars, Iowa, United States Oakleaf Property Management Full time

    Job OverviewThe Facilities Maintenance Specialist will oversee the comprehensive upkeep of the residential complex, ensuring all aspects of daily maintenance operations are managed effectively under the guidance of the Site Manager.Key ResponsibilitiesThe role encompasses a variety of essential tasks, including but not limited to:Performing electrical,...

  • Window Cleaning Specialist

    2 days ago

    Le Mans, Pays de la Loire, United States Fish Window Cleaning Full time

    About the JobWe are seeking a skilled and detail-oriented Window Cleaning Specialist to join our team at Fish Window Cleaning. As a Window Cleaning Specialist, you will be responsible for cleaning glass surfaces at commercial and residential locations, including retail stores, office buildings, and malls.Key Responsibilities:Clean glass surfaces at...

  • Electrical Test Specialist

    1 week ago

    Gondrecourt-le-Château, Grand Est, United States Actalent Full time

    Job Title: Electrical Test SpecialistActalent is seeking a detail-oriented Electrical Test Specialist to validate electrical components, circuits, and systems, ensuring adherence to design requirements.Key Responsibilities:Validate electrical components, circuits, and systems to ensure adherence to design requirementsDevelop and execute test cases for...

  • Seasonal Culinary Specialist

    2 weeks ago

    Le Pontet, Provence-Alpes-Côte d'Azur, United States Goldminers Daughter Lodge Full time

    Job OverviewWinter Seasonal Culinary Specialist in Café & Saloon KitchensHave you ever imagined the experience of working in a picturesque ski resort base lodge?As many of our team members would share, it's truly remarkable. Discover what Goldminer's Daughter Lodge has to offer:Work Hours: Average 40 hours per weekCompensation: $15.25 per hourPosition...

  • Correctional Security Specialist

    2 weeks ago

    Le Flore, United States The State of Oklahoma Full time

    Become a vital member of the Oklahoma Department of CorrectionsWe are actively looking for Correctional Security Specialists for various roles across the State of Oklahoma.Applicants should be prepared to participate in an extensive training program that includes an immersive live-in academy experience.Upon successful completion of the training, candidates...

  • Professional Window Cleaning Specialist

    2 weeks ago

    Le Pontet, Provence-Alpes-Côte d'Azur, United States Blue Skies Admin Services Full time

    Join Our Team as a Professional Window Cleaning Specialist!At Blue Skies Admin Services, we are seeking dedicated individuals to become part of our exceptional window cleaning crew. Our team members are recognized as the finest in the industry.If you are in search of a rewarding window cleaning role where your contributions are valued and acknowledged, we...

  • Procurement Specialist

    3 days ago

    Le Roy, Minnesota, United States Omega Ventures Full time

    We are seeking a highly skilled Procurement Specialist to join our team at Omega Ventures. As a key member of our purchasing department, you will be responsible for the procurement of raw materials, spare parts, and packaging materials.Key Responsibilities:Process and plan procurement of raw materials, spare parts, and packaging materialsProcess inquiries...

  • Beauty Specialist

    5 days ago

    Gondrecourt-le-Château, Grand Est, United States European Wax Center Full time

    About European Wax CenterWe are a leading provider of waxing services, dedicated to delivering exceptional experiences to our clients. Our team is passionate about helping individuals achieve smooth, radiant skin.Job SummaryWe are seeking a skilled Wax Specialist to join our team at European Wax Center. As a Wax Specialist, you will be responsible for...

  • Facilities Maintenance Specialist

    2 weeks ago

    Le Mars, Iowa, United States Oakleaf Property Management Full time

    Job OverviewThe Facilities Maintenance Specialist will oversee the comprehensive upkeep of the apartment community, ensuring all maintenance operations run smoothly under the guidance of the Site Manager.Key ResponsibilitiesThe essential duties of this role include, but are not limited to:Performing tasks related to electrical systems, plumbing, carpentry,...

  • Window Cleaning Specialist

    4 days ago

    Le Mans, Pays de la Loire, United States Fish Window Cleaning Full time

    About the JobWe are seeking a skilled and detail-oriented Window Cleaning Specialist to join our team at Fish Window Cleaning. As a key member of our team, you will be responsible for providing exceptional window cleaning services to our commercial and residential clients.ResponsibilitiesClean glass surfaces at commercial and residential locations, including...

  • Travel Imaging Specialist

    2 weeks ago

    Magstatt-le-Bas, Grand Est, United States Epic Travel Staffing Allied Full time

    Epic Travel Staffing Allied is seeking a travel Imaging Specialist for a temporary position. Position Overview We are looking for a dedicated Imaging Specialist to join our team for a travel assignment. Job Specifications Specialty: Imaging SpecialistDiscipline: Allied Health ProfessionalDuration: 13 weeksHours: 36 hours per weekShift: 12-hour night...

  • Automotive Repair Specialist

    2 weeks ago

    Magstatt-le-Bas, Grand Est, United States Madhatterautorepair Full time

    Position: Automotive Repair SpecialistCompany: Mad Hatter Auto RepairCompensation: $50,000 - $80,000 annuallyMad Hatter Auto Repair is recognized for its outstanding service and dedication to customer satisfaction. We are currently looking for a talented and knowledgeable Automotive Repair Specialist to become a part of our team. Our shop offers a wide array...

  • Facilities Maintenance Specialist

    1 week ago

    Le Mars, Iowa, United States Oakleaf Property Management Full time

    Job OverviewThe Facilities Maintenance Specialist will oversee the comprehensive upkeep of the residential community, ensuring all maintenance operations run smoothly under the guidance of the Site Manager.Key ResponsibilitiesThe role encompasses a variety of essential tasks, including but not limited to:1) Performing electrical, plumbing, carpentry,...

  • Safety and Security Specialist

    2 weeks ago

    Gondrecourt-le-Château, Grand Est, United States Regions Hospital Full time

    Position Overview Regions Hospital is seeking a dedicated Safety and Security Specialist to enhance our team. This full-time role is pivotal in ensuring a secure and safe atmosphere for all patients, visitors, and staff members. The Safety and Security Specialist will undertake a range of responsibilities, including but not limited to: - Conducting regular...

  • Rehabilitation Specialist

    2 weeks ago

    Gondrecourt-le-Château, Grand Est, United States Regions Hospital Full time

    Regions Hospital is proud to present an opportunity within our innovative transitional care unit (TCU). Our focus is on delivering exceptional care to adult patients requiring short-term rehabilitation. As a Rehabilitation Specialist, you will be an integral part of our dedicated team, contributing to a supportive and enriching work environment. Key...

  • Traveling CT Imaging Specialist

    2 weeks ago

    Magstatt-le-Bas, Grand Est, United States Cure Healthcare Staffing Full time

    Cure Healthcare Staffing is currently in search of a traveling CT Imaging Specialist for an exciting opportunity.Position Overview & RequirementsSpecialty: CT Imaging SpecialistDiscipline: Allied Health ProfessionalDuration: 13 weeks36 hours per weekShift: 12 hours, flexibleEmployment Type: TravelThis role requires a valid state license and AHA BLS...

  • Agricultural Machinery Service Specialist

    2 weeks ago

    Le Mars, Iowa, United States gpac Full time

    Job Overview Agricultural Machinery Service Specialist Join a reputable multi-location agricultural equipment dealership seeking a skilled Agricultural Machinery Service Specialist. This role emphasizes the significance of precision in work and the importance of customer satisfaction. Responsibilities include performing diagnostics, service repairs, and...

  • Event Production Specialist

    5 days ago

    Magstatt-le-Bas, Grand Est, United States BallerTV Full time

    Job DescriptionJob Title: Event Production SpecialistJob Type: Weekend Work - ContractLocation: RemoteJob Description:We are seeking a highly skilled Event Production Specialist to join our team at BallerTV. As an Event Production Specialist, you will be responsible for setting up and operating our live streaming system at various sports events across the...

  • Security Transport Specialist

    2 weeks ago

    Magstatt-le-Bas, Grand Est, United States Rochester Armored Car Full time

    Rochester Armored Car INC is seeking a dedicated Security Transport Specialist.Are you looking to advance from a traditional security position to a more rewarding career? If you are recognized for your dependability and integrity, and prefer a role with consistent hours, this opportunity may be ideal for you.We are in search of a Security Transport...

  • Radiology Intervention Specialist

    1 week ago

    Magstatt-le-Bas, Grand Est, United States Nebraska Cancer Specialists Full time

    Are you dedicated to advancing patient care in Oncology and Hematology?Nebraska Cancer Specialists (NCS) is devoted to delivering exceptional care to individuals facing oncological and hematological challenges, ensuring a compassionate approach while promoting advancements in cancer treatment through research and education. Our goal is to be recognized as...