Validation Engineer

4 weeks ago

St Paul, United States CareerBuilder Full time

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 facilitys 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.
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 ones 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 ones 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:
Bachelors of Science in related field or 5 years relevant experience, preferably in a regulated pharmaceutical industry with 2 years in a validation role. (Medical device and food industry also considered)

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
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 centurys experience in providing science-driven solutions to optimize the health, wellbeing and productivity of the worlds animals.
Bimedas 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.
Bimedas 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
Read

4

times

Last modified on Thursday, 14 March 2024 20:00

#J-18808-Ljbffr

  • Validation Engineer

    2 weeks ago

    St Paul, United States Bimeda Full time

    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...

  • Data Validation Engineer

    2 weeks ago

    St Albans, United States Us Orthopartners Full time

    USOP is a dynamic and innovative Orthopaedic Healthcare company committed to leveraging cutting-edge technologies to drive business success. We seek a skilled and detail-oriented Data Validation Engineer to join our Alpharetta, GA-based team in ensuring our data's accuracy, integrity, and reliability through Azure Data Factory. The Data Validation Engineer's...

  • Validation Engineer III

    2 weeks ago

    St Louis, United States Kindeva Drug Delivery Full time

    Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture many more tomorrows. Ready to work with purpose? Look no...

  • Quality Engineer

    3 weeks ago

    St Paul, United States STROM MINNESOTA Full time

    Strom Minnesota is currently looking for a Quality Engineer for our client in Eagan, MN. **Local applicants ONY** Should be located within a 30 mile radius of Eagan, MN. Quality Engineer Job Duties Prepare validation, Qualification and verification plans and reports.Perform validations (IQ, OQ, PQ) for new product development and leading transfer to...

  • Quality Engineer

    4 weeks ago

    St Paul, United States STROM MINNESOTA Full time

    Strom Minnesota is currently looking for a Quality Engineer for our client in Eagan, MN. Local applicants ONY Should be located within a 30 mile radius of Eagan, MN. Quality Engineer Job Duties Prepare validation, Qualification and verification plans and reports. Perform validations (IQ, OQ, PQ) for new product development and leading transfer to production....

  • Process Engineer

    5 days ago

    St Paul, United States Fives Full time

    Fives Group is looking for an experienced Process Engineer to join our team in the greater St. Paul, MN area. Responsibilities Plans and conducts work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard accepted methods. Performs most assignments with instructions as to general results...

  • Product Development Engineer 3

    17 hours ago

    St Paul, United States Custom Search Full time

    Our smaller bioelectronic medical device client is adding a Product Development Engineer to the team. The Engineer will be responsible for technical leadership and timely development of new technologies and devices to support the needs of the customer. This requires representation for the department in inter-company relations and providing technical...

  • Test Engineering Intern

    3 days ago

    St Paul, United States Multi-Tech Systems Full time

    SUMMARY: The Test Engineer Intern will work alongside the Test Development team in product validation and migration of new products into manufacturing. ESSENTIAL DUTIES AND RESPONSIBILITIES: Conduct testing of electronic devices to validate functionality and performance as part of the New Product Introduction process. Build and test prototype PCBAs Automate...

  • Senior Quality Engineer

    1 week ago

    St Paul, United States Innovize Full time

    Job DescriptionTitle: Senior Quality Engineer Reports to: Senior Quality Engineer Manager Summary: Quality Engineer will drive a Culture of Quality and Continuous Improvement within the company by promoting adherence to the Quality System requirements across all departments. Quality Engineer is responsible for ensuring customer, company, and regulatory...

  • Civil Engineer Minnesota

    1 week ago

    St Paul, United States NxT Level Full time

    Civil Engineer Join our dynamic team in Saint Paul, Minnesota! Our organization, a leading engineering and environmental consulting firm, specializes in WATER (watersheds + water resources), ECOLOGY (ecosystems + natural resources), and COMMUNITY (civil engineering, landscape architecture + planning). Brief Description: We're seeking a Civil Engineer to...

  • Sr. Controls Engineer

    7 days ago

    St Paul, United States SkyWater Search Partners Full time

    We are partnering with a leading biotechnology company dedicated to developing and commercializing innovative products to address the unmet medical needs of patients with chronic and life-threatening conditions. Our mission is to transform the lives of patients through science, innovation, and a commitment to excellence. Position Overview: We are seeking a...

  • Project Engineer, Continuation

    2 weeks ago

    St Paul, United States Scanlan Int'l Full time

    Job Description Job Description The Project Engineer professional is responsible for all technical and engineering documentation of their assigned projects. They plan, schedule, predict, and manage all the technical tasks for Scanlan Single-Use Devices and Re-Usable Surgical Instruments, to assure accuracy, proper resources, and quality through their product...

  • Quality Engineer

    4 days ago

    St Paul, United States William H Hunter Recruiting Full time

    Seeking an experienced Quality Engineer. Excellent career opportunity. Responsibilities: * Oversee first article, PPAP, capability analysis, gage R & R as deemed necessary for customer programs. To include planning verification, validation, monitoring inspection and test activities specific to the product. * Review and confirm product quality requirements...

  • Quality Engineer

    3 days ago

    St Paul, United States William H Hunter Recruiting Full time

    Seeking an experienced Quality Engineer. Excellent career opportunity. Responsibilities: * Oversee first article, PPAP, capability analysis, gage R & R as deemed necessary for customer programs. To include planning verification, validation, monitoring inspection and test activities specific to the product. * Review and confirm product quality requirements...

  • Civil Engineer

    1 week ago

    St Paul, United States NxT Level Full time

    Job Description Job Description Civil Engineer Join our dynamic team in Saint Paul, Minnesota! Our organization, a leading engineering and environmental consulting firm, specializes in WATER (watersheds + water resources), ECOLOGY (ecosystems + natural resources), and COMMUNITY (civil engineering, landscape architecture + planning). Brief Description: We're...

  • Project Engineer, Continuation

    5 days ago

    St Paul, United States Scanlan International, Inc. Full time

    The Project Engineer professional is responsible for all technical and engineering documentation of their assigned projects. They plan, schedule, predict, and manage all the technical tasks for Scanlan Single-Use Devices and Re-Usable Surgical Instruments, to assure accuracy, proper resources, and quality through their product lifecycle. This includes Design...

  • R&D Engineer

    2 weeks ago

    St. Paul, United States Talent Software Services Full time

    R&D Engineer III Job Summary: Talent Software Services is in search of a R&D Engineer for a contract position in St. Paul, MN. The opportunity will be one year with a strong chance for a long-term extension. Position Summary: Work with R&D Design project teams to develop and execute on plans to create, verify, and validate new technology, products,...

  • Structural Engineer

    2 weeks ago

    St Paul, United States AMI Consulting Engineers Full time

    Location: Superior, WI or St. Paul, MN Reports to: Structural and Marine Engineering Managers Department: Structural and Marine Engineering Status: Full-time Structural Engineer (5-15 years’ experience) Are you a structural engineer with solid design experience that is seeking an opportunity to use your strengths and manage various projects while further...

  • R&D Engineer

    1 week ago

    St Paul, United States TALENT Software Services Full time

    Are you an experienced R&D Engineer with a desire to excel? If so, then Talent Software Services may have the job for you! Our client is seeking an experienced R&D Engineer to work at their company in St Paul, MN.Position Summary: Work with R&D Design project teams to develop and execute on plans to create, verify, and validate new technology, products,...

  • R&D Engineer

    1 week ago

    St Paul, United States TALENT Software Services Full time

    Are you an experienced R&D Engineer with a desire to excel? If so, then Talent Software Services may have the job for you! Our client is seeking an experienced R&D Engineer to work at their company in St Paul, MN.Position Summary: Work with R&D Design project teams to develop and execute on plans to create, verify, and validate new technology, products,...