Validation and Qualification Engineer

    MSD Published: February 16, 2021
    Location
    Krems an der Donau, Austria
    Job Type

    Description

    Job Description

    Our Animal Health division is a trusted global leader in veterinary medicine, dedicated to the health and well-being of animals. We are a global team of professionals working together to make a positive difference in animal care and the world’s food supply and have a deep sense of responsibility towards our customers, consumers, animals, society and our planet. We offer one of our industry’s most innovative portfolio of products, services and technologies that serve to prevent, treat, and control diseases across all major farm and companion animal species.

    Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

    For our new production facility in Krems we are looking for an experienced

    Validation and Qualification Engineer (m/f/d)

    Full-time, as soon as possible

    with several years of experience in industry. You will support the management, the quality entity and the project teams during an intensive start-up phase. The position is reporting directly to the Site Validation Lead Krems.

    The primary purpose of the position is to manage and drive Qualification and Validation related activities on site ensuring continued compliance with the principles of GMP as defined in current European and Austrian statute and guidance.

    Key attributes of the position:

    • Leading assigned Qualification and Validation activities
    • Issue of Qualification Plans, Protocols and Reports and support different Equipment and Systems owners by providing technical knowledge
    • Planning and execution of the qualification of equipment and systems as well as validation of processes together with the equipment/process owner, supporting contractors and vendors
    • Support to set-up a site program and undertake tasks for aseptic process validation (Media Simulation) and Cleaning Validation programs
    • Perform Cycle development, Qualification and Re-Qualification of sterilization processes (thermal, chemical, other physical methods)
    • Establish Risk Assessment programs for Qualifications and Validations
    • Participate and moderate Risk Analysis of equipment, systems and processes
    • Issue and updating of standard operating procedures for qualification and validation based on internal and external guidelines and standards
    • Planning and execution of Computerized Systems Validation (CSV) in cooperation with IT and Process Automation
    • Supporting and facilitating in problem solving
    • Supporting improvement projects and re-validation activities
    • Supporting Change Management process on site and delivering assigned tasks in a timely manner
    • Supporting Deviation Management process and CAPA management process on site
    • Cooperation with peers and experts at site as well as within the Network of our Manufacturing division
    • Management of external contractors for C&Q as well as validation activities
    • Issue, execution and updating of the Project Validation Master Plans with support from senior validation team members
    • To be up to date with GMP, Engineering and Company standards and effectively applying these standards at job
    • Assist training new employees in equipment qualification, risk assessments and validation exercises
    • Responsible for being compliant with the Company safety guidelines and must be capable of recognizing unsafe situations and acting to be safe during job
    • Tracking qualification/re-qualification activities and must be able to communicate adequately (verbally/writing) to all levels within the organisation

    Qualification and Experience:

    • Degree in (Bio)Chemistry, Process Technology, Biotechnology, Pharmaceutical Technology, Engineering or comparable
    • Work experience or theoretical knowledge in Aseptic Processing operations in a Pharmaceutical Company
    • Hands-On-Experience or knowledge on (Bio) Process Technology, Microbiology, Aseptic Processing and Equipment Design
    • Experienced in or knowledge on the qualification and validation of cleanrooms, sterilization processes and aseptic process media simulation
    • Experience or knowledge in CSV
    • Hands on experience with application of risk management tools
    • Experience in working in teams and following instructions
    • Experience or knowledge in change management, deviations and CAPAs management
    • Experience or knowledge in the use of continuous improvement tools and methodologies
    • Energetic and enthusiastic team player with innovative mindset, strategic, analytical and problem-solving skills
    • Excellent communication, interpersonal and organizational skills
    • Task management skills, ability to lead and motivate individuals (incl. external contractors) to complete tasks
    • Accuracy, versatility, adherence to delivery dates and love for details
    • Flexibility, positive attitude, cooperativeness and friendliness
    • Very good knowledge of MS-Office applications
    • Fluency in written and spoken German and English

    We offer:

    • Unique possibility to participate in the establishment of a state-of-the-art production site
    • Diversified responsibilities in an international surrounding
    • Collaboration with professional and highly motivated team members
    • Participation in a respectful and positive working climate
    • Attractive career opportunities as well as good training and development possibilities

    The minimum annual salary for this position is EUR 40.776,26 and varies according to the qualifications and experience of the successful candidate.

    Who we are …

    We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

    What we look for …

    In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth .

    INVENT.

    IMPACT.

    INSPIRE.

    We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

    Search Firm Representatives Please Read Carefully
    Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

    Employee Status:

    Regular

    Relocation:

    Domestic

    VISA Sponsorship:

    No

    Travel Requirements:

    10%

    Flexible Work Arrangements:

    Flex Time

    Shift:

    Valid Driving License:

    Hazardous Material(s):

    APPLY HERE