Technical Expert Engineering CSV (Senior Engineer)

Singapore   |   full time   |   Job ID: 6861 

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. 

Your Benefits:

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.

Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

How to apply:

Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.

Please note:

Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your Recruiter.

We are looking forward receiving your application.