We have other current jobs related to this field that you can find below

  • Validation Engineer/Manager

    3 months ago

    Le Sueur, United States Bimeda Full time

    Job DescriptionJob DescriptionSalary: $92 - 115,000 Annually, DOEThe Validation Engineer/Manager  reports to the Director of Operations (with a dotted line reporting responsibility to the Director of Technical Operations) and is responsible for the execution and regulatory compliance of the validation program.  The Validation Manager is well-versed in the...

  • Validation Engineer

    3 days ago

    Le Sueur, United States Scismic Inc Full time

    Job DescriptionJob DescriptionScismic 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...

  • Validation Specialist

    2 days ago

    Le Sueur, United States Bimeda Full time

    Job DescriptionJob DescriptionSalary: Purpose of the Position/Role SummaryThe Validation Specialist reports to the Validation Manager. The specialist initiates and executes validation studiesthroughout the facility.Role Specific Requirements: Interact with all levels of management and staff to manage and facilitate the validation process from inception to...

  • Process Engineer

    3 weeks ago

    Le Sueur, United States Cambria Full time

    Job Description:This position is responsible for helping implement mechanical and procedural initiatives to maintain and improve the Cambria manufacturing and polishing processes. The Process Control Engineer tests, troubleshoots, and redesigns existing processes and systems to improve Processing Facility operations.Essential Duties and...

  • Process Engineer

    4 weeks ago

    Le Sueur, United States Cambria Full time

    Job Description: This position is responsible for helping implement mechanical and procedural initiatives to maintain and improve the Cambria manufacturing and polishing processes. The Process Control Engineer tests, troubleshoots, and redesigns existing processes and systems to improve Processing Facility operations. Essential Duties and Responsibilities: ...

  • Electro-Mechanical Validation Engineer

    7 days ago

    Gondrecourt-le-Château, Grand Est, United States Horton, Inc. Full time

    Position Title: Electro-Mechanical Validation EngineerLocation: Roseville, MNJob Type: Regular Full-TimeOpenings: 1Category: EngineeringCompany Overview:Horton, Inc. is a prominent family-owned enterprise recognized for its innovative engine cooling solutions across the globe. With a commitment to reliability and service, we are seeking a skilled...

  • Maintenance Manager

    6 days ago

    Le Sueur, United States Bimeda Full time

    The Maintenance Manager plays a critical role in ensuring the smooth and efficient operation of the manufacturing facility. This position is responsible for the overall maintenance strategy, encompassing preventive, predictive, and corrective maintenance activities. The Maintenance Manager will lead a team of skilled technicians, fostering a culture of...

  • Sanitation Operations Manager

    7 days ago

    Le Sueur, Minnesota, United States Michael Foods Full time

    Company Overview:Michael Foods, Inc. stands as a prominent entity in the food processing and distribution sector, specializing in egg products, refrigerated grocery items, and potato-based offerings. We present a variety of exciting career opportunities across our organization, allowing you to develop your skills, enhance your career, and contribute...

  • Process Control Technician

    3 months ago

    Le Sueur, United States Cambria Full time

    Job Description:The Process Control Technician position is responsible for helping to implement mechanical and procedural initiatives, while the overall objective is to maintain and improve upon the Cambria manufacturing and polishing processes, ensuring consistency and increasing yield. Process improvement and metrics are essential to this role. This is a...

  • Process Control Specialist

    1 day ago

    Le Sueur, Minnesota, United States Cambria Full time

    Job Summary:The Process Control Specialist position at Cambria is responsible for implementing mechanical and procedural initiatives to maintain and improve manufacturing and polishing processes, ensuring consistency and increasing yield. This role requires a strong technical background and hands-on management skills.Key Responsibilities:Perform process...

  • Manager of Electrical and Automation Engineering

    6 days ago

    Magstatt-le-Bas, Grand Est, United States Cameron Craig Group Full time

    Position Title: Electrical and Automation Engineering ManagerOverview:We are seeking a dedicated Electrical and Automation Engineering Manager to join our dynamic Engineering team at Cameron Craig Group. This role is pivotal in driving innovation and excellence in the mobile electrification sector.Key Responsibilities:As the Electrical and Automation...

  • Facilities Maintenance Supervisor

    1 day ago

    Le Sueur, Minnesota, United States Bimeda Full time

    Job OverviewSalary: $100-120,000 annually DOEThe Facilities Maintenance Supervisor is essential in guaranteeing the effective and seamless functioning of the manufacturing site. This role encompasses the comprehensive maintenance strategy, which includes preventive, predictive, and corrective maintenance tasks. The Facilities Maintenance Supervisor will...

  • Engineering Project Manager

    6 days ago

    Magstatt-le-Bas, Grand Est, United States Affinity Executive Search Full time

    Job Title: Project Engineering ManagerLocation: Omaha, NebraskaSalary: $120-150K plus bonusJob Overview: We are seeking an experienced Engineering Manager. The ideal candidate will be results-oriented, self-motivated, analytical, and capable of adapting to the evolving demands of the organization and our clients. This role involves hands-on management of...

  • Engineering Project Manager

    6 days ago

    Magstatt-le-Bas, Grand Est, United States Affinity Executive Search Full time

    Job Title: Project Engineering ManagerLocation: Omaha, NebraskaSalary: $120-150K plus bonusJob Overview: We are seeking a skilled Engineering Manager to oversee our project engineering initiatives. The ideal candidate will demonstrate a results-oriented approach, possess strong self-management skills, and be adept at utilizing data to drive decisions while...

  • Feed Production Associate

    6 days ago

    Le Sueur, Minnesota, United States United Farmers Cooperative Full time

    Job OverviewRole Summary: Support various aspects of feed production operations.Key Responsibilities:Operational Duties:Assist in coordinating the daily production schedule for local mixes to facilitate efficient custom mixing and grinding.Provide support to the production supervisor as required.Maintain cleanliness and organization in the feed additive...

  • Feed Production Assistant

    4 weeks ago

    Le Sueur, United States United Farmers Cooperative Full time

    Job DescriptionJob DescriptionDescription:Assist in all areas of feed production.Communicates with patrons and employees in a manner that will create support and loyalty for United Farmers Cooperative.Major Areas of Accountability: OperationsHelps organize daily schedule of required local mix to expedite custom mixing and grinding.Assists the production...

  • Subway Store Assistant

    3 months ago

    Le Sueur, United States Circle K Full time

    Store 2746802Q: 420 North Main, Le Sueur, Minnesota 56058 Availability - Shift/Days Flexible Availability The position includes, but is not limited to, the following essential job duties, responsibilities, and requirements: RESTAURANT ASSISTANT MANAGER JOB SUMMARY: This position assists the Restaurant Manager (RM) with daily operations of the restaurant...

  • Production Supervisor

    3 weeks ago

    Le Sueur, Minnesota, United States Covia Full time

    Covia is a leading supplier of minerals and material solutions to the industrial and energy markets. Covia's rich legacy includes many achievements across industries and capital success through partnership. Our ability to deliver the right product, to the right place, at the right time, is unmatched. Just as strong is our commitment to building partnerships...

  • Production Supervisor

    3 weeks ago

    Le Sueur, United States Covia Full time

    Description Covia is a leading supplier of minerals and material solutions to the industrial and energy markets. Covia's rich legacy includes many achievements across industries and capital success through partnership. Our ability to deliver the right product, to the right place, at the right time, is unmatched. Just as strong is our commitment to building...

  • Professional Freight Transport Operator

    7 days ago

    Le Sueur, Minnesota, United States Cambria Full time

    Job Overview: This role involves the timely and precise delivery of goods to a designated route of clients, ensuring a courteous and professional interaction. The individual will be tasked with both driving responsibilities and the loading and unloading of trailers, adhering to Standard Operating Procedures as necessary, which may constitute up to 40% of the...

Validation Engineer/Manager

2 months ago

Le Sueur, United States Bimeda Full time
Job DescriptionJob DescriptionSalary: $92 - 115,000 Annually, DOE

The Validation Engineer/Manager  reports to the Director of Operations (with a dotted line reporting responsibility to the Director of Technical Operations) and is responsible for the execution and regulatory compliance of the validation program.  The Validation Manager is well-versed in the generation, execution, modification, and summation of Validation documents to ensure Good Documentation Practices within pharmaceutical operations. This role serves to ensure products and processes are maintained in a validated state and compliant with regulatory and cGMP requirements throughout the product lifecycle. This is accomplished through interaction and coordination of activities with all relevant departments within the organization.   


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 for Technical Transfer from  Research and Development and supports the 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.
  • Assign equipment asset number to 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 required during the change control process, deviation process and batch record review process.
  • Validate batch record calculations sheets as required.
  • Help develop and maintain drawings and diagrams for regulatory agencies and in plant use.
  • Support the North American Project Manager and other management in equipment selection and facility modifications. This includes supporting URS development and assisting in preparing capital equipment expense requests.
  • Support the North American EHS Manager and other management in environmental activities as required.
  • Perform other duties as assigned.



We are unable to support/sponsor any visa or immigration cases 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:

Essential:

  • 7 years relevant experience in a regulated pharmaceutical industry with 5 years in a validation role
  • Bachelors degree in Science or engineering
  • Knowledge of validation strategies and execution techniques, validation requirements and regulatory expectations for GMP compliance.
  • 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
  • Ability to work both independently and in a team.

Desired: 

  • Master’s degree in science or related field



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.


Your application to us; assumes you have read and agree with our privacy policy