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Biotools Validation Engineer

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Merck Group

3mo ago

  • Job
    Full-time
    Entry, Junior, Mid & Senior Level
  • Science
    Healthcare
  • Cork

AI generated summary

  • You need a B.Sc. in a related field, strong motivation, good communication skills, teamwork, time management, and problem-solving abilities. Proven technical writing skills are essential.
  • You will execute validations, prepare protocols, ensure compliance, train teams, monitor projects, investigate issues, lead risk assessments, and uphold EHS and quality standards in daily tasks.

Requirements

  • B.Sc. in an appropriate Science/Quality Assurance discipline or equivalent
  • Thorough, practical and persistent self-starter with strong motivation
  • Good verbal and presentation skills
  • Strong written communication skills with proven technical and report writing skills
  • Demonstrated success working in a team environment
  • Effective time-management skills to meet project schedules
  • Good problem-solving skills

Responsibilities

  • Execute and complete process, systems and equipment validations in accordance with Validation Master Plans, company policies and project schedules.
  • Prepare, execute and complete Validation Protocols and Reports, ensuring compliance to all relevant Quality standards and Regulatory requirements.
  • Participate in cross-functional teams to establish validation strategies and objectives to support process and equipment changes.
  • Ensure all departments understand and comply with requirements defined in validation programmes, provide training as necessary.
  • Maintain ongoing understanding and knowledge of requirements for validation in compliance with applicable regulations and guidance documents, provide updates to department management and cross-functional teams.
  • Participate in the review of validation practices and trends, identify opportunities for continuous improvement and complete improvement projects.
  • Monitor the progress of validation projects to ensure adherence to schedule and provide regular stakeholder updates.
  • Ensure thorough investigation of Quality and Validation issues using Root Cause Analysis methodology and implementation of robust corrective and preventative actions to prevent recurrence.
  • Lead and co-ordinate Risk Mitigation initiatives such as FMEA and Risk Assessments.
  • Adhere to all company EHS guidelines and Quality procedures.
  • Perform other duties as required

FAQs

What is the main responsibility of the Biotools Validation Engineer?

The main responsibility of the Biotools Validation Engineer is to design and execute validation projects and strategies to support the implementation of Validation Master Plans and Qualification programmes.

What qualifications are required for this position?

A B.Sc. in an appropriate Science/Quality Assurance discipline or equivalent is required for this position.

What skills are important for a Biotools Validation Engineer?

Important skills include being a thorough and persistent self-starter, possessing good verbal and presentation skills, strong written communication and technical report writing skills, effective time-management, and good problem-solving skills.

Will the Biotools Validation Engineer work in a team environment?

Yes, the Validation Engineer will work as part of a cross-functional team to deliver continuous improvements and exceed customer expectations.

Are there opportunities for continuous improvement in this role?

Yes, the Validation Engineer will participate in the review of validation practices and trends, identify opportunities for continuous improvement, and complete improvement projects.

What type of training will the Biotools Validation Engineer provide?

The Validation Engineer will provide training to ensure all departments understand and comply with the requirements defined in validation programmes.

What does the job entail in terms of compliance?

The job entails preparing, executing, and completing Validation Protocols and Reports while ensuring compliance with relevant Quality standards and Regulatory requirements.

How does the company view diversity and inclusion?

The company celebrates all dimensions of diversity, believing it drives excellence, innovation, and human progress, and is committed to creating access and opportunities for all.

What safety guidelines must the Biotools Validation Engineer adhere to?

The Validation Engineer must adhere to all company Environmental, Health, and Safety (EHS) guidelines and Quality procedures.

Are there other duties assigned to the Biotools Validation Engineer?

Yes, the role may include performing other duties as required.

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Merck Group

We are Merck, a vibrant science and technology company. Science is at the heart of everything we do.

Manufacturing & Electronics
Industry
10,001+
Employees
1668
Founded Year

Mission & Purpose

This channel is not intended for U.S. and Canadian visitors. Merck operates in the U.S. and Canada as EMD Serono in Healthcare, MilliporeSigma in Life Science and EMD Electronics in Electronics. An unaffiliated and unrelated company, Merck & Co., Inc., Kenilworth, NJ, US holds the rights in the trademark MERCK in the U.S. and Canada. _______________________________ We are Merck, a leading global science and technology company headquartered in Germany. We are curious explorers, courageous pioneers, and ingenious inventors. Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Life Science, Healthcare, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and the planet. We believe in the positive power of science and technology. It has determined our actions since 1668 and inspires us to continue researching for a future worth living. As a family-owned company with over 350 years of experience, we stand for sustainability, responsibility, and innovative strength. We take pride in being a diverse and inclusive company that values and fosters the talents and abilities of our employees. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. Work your Magic and join Merck