As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.
We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.
Technical Expert Engineering CSV
We are looking for a result driven CSV Expert to become one of the pioneers in our newly established manufacturing plant in Singapore. The candidate will be responsible for commissioning and qualification oversight for our automated and IT systems, to ensure our compliance to the company procedures, cGMP expectations and regulatory requirements.
Your responsibilities:
- Provides expertise in performing Computerized Systems Validation.
- Primary personnel for the qualification of Computerized Systems including Automation Systems (PCS 7, EMS, MES) and GMP equipment qualifications operating within the framework of regulations (GxP, 21CFR11, etc.)
- Perform collaborative work with the Compliance Engineering team on other CQV activities.
- Coordinate with both internal and external teams (manufacturing, engineering, quality, vendors, contractors, etc.) to achieve the site objectives.
- Prepare, review, and approve of SOPs and qualification-related documentations (protocols and reports)
- Ensure that the qualification strategy is sound and adhere to company standards and regulatory requirements.
- Investigate deviations and write deviation reports and findings.
- Raise and follow-up change control records.
What you have to offer:
- Degree in Engineering/Science or related studies.
- Minimum of 8 years’ experience in pharma/ biotech manufacturing industry with at least 5 years in CSV activities.
- High level of understanding in Regulatory compliance
- Familiar with working in a GxP environment and keeping up to date with current GxP, with flexibility to change as needed due to new regulatory requirements and technologies, as relevant for clinical and commercial supply.
- In-depth knowledge in Computer System Validation (CSV), GAMP 5, 21 CFR Part 11, ER/ES, validation lifecycle, current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in a biotech facility
- Good knowledge of GxP, GDP, CQV approaches including Validation Lifecycle approach (URS, DQ, FAT/SAT, IOQ, CSV, Cleaning/ Thermal Validation etc.), regulatory requirements and best industry practices.
- Competent in technical writing and presentations. Proficient in MS Office Suite (Microsoft Word, PowerPoint, Excel).
- Problem solver and has ability to make decisions.
- Able to work independently, self-starter, self-motivated and task oriented.
- Good communication skills and able to openly communicate and escalate any relevant issues.
- Develop positive relationship with a strong set of interpersonal skills.
Benefits for you
We offer a competitive compensation package which will be determined by the contract type and selected candidate’s qualifications and experience.
