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Takeda - Csv Engineer

3 weeks ago

Singapore Amaris Consulting Full time

**Who are we? **:**Amaris Consulting** is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade - this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.

**Brief Call**: Our process typically begins with a brief virtual/phone conversation to get to know you The objective? Learn about you, understand your motivations, and make sure we have the right job for you

**Interviews** (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities

**Case study**: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.

We look forward to meeting you
**Job description**:
We are seeking a skilled and motivated CSV Engineer to join our growing team of Life Science Experts. You should have a strong background in Computer System Validation (CSV) within the Life Sciences sector, with a focus on ensuring compliance with regulatory standards and maintaining the integrity of the systems.
- Key Responsibilities:

- Develop, review, and maintain validation documentation, including validation plans, protocols, and reports.
- Conduct risk assessments and ensure that all computer systems comply with regulatory requirements and internal policies.
- Collaborate with cross-functional teams to ensure the successful implementation and validation of computer systems.
- Perform engineering validation activities, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
- Participate in audits and inspections, providing necessary documentation and evidence of compliance.
- Stay updated on industry trends, regulations, and best practices related to CSV and the Life Sciences sector.
- Qualifications:

- Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field.
- 4 to 6 years of experience in Computer System Validation within the pharmaceutical or life sciences industry.
- Strong knowledge of regulatory requirements (e.g., FDA, EMA, GxP) and industry standards related to CSV.
- Proficiency in validation documentation and engineering validation processes.
- Excellent analytical and problem-solving skills.
- Strong communication and interpersonal skills, with the ability to work collaboratively in a team environment.
- Detail-oriented with a commitment to quality and compliance.
- Preferred Skills:

- Experience with electronic laboratory notebooks (ELN), laboratory information management systems (LIMS), or other relevant software.
- Familiarity with project management methodologies and tools.
- Certification in validation or quality assurance is a plus.