Senior Validation Engineer

1 week ago

Singapore NUSANTARA PRIME CONSULTING PTE LTD Full time

**Responsibilities**:

- Monitor day-to-day Validation activities in accordance with approved SOPs / Plan / Policies for a large scale, multi-product, GMP biotech contract manufacturing facility
- Participate in review and approval of Validation Protocols / Reports including site discrepancies and deviations investigation / closure
- Support / participate in validation activities during facility startup / shutdown / changeover and routine GMP operations
- Support / participate in Site Validation Maintenance Program and implementation of department training requirements
- Develop Validation Plans for a small to medium scale change implementation project and ensure the validation execution activity meets scheduled timelines
- Active coordination with internal and external validation resources to achieve department / project goals
- Liaise with system owners, quality unit and other relevant departments to ensure scope, execution and reporting of Site Validation Program meet expectations
- Review & assess Site Change Controls, implementation of Validation CAPAs and subsequent closure
- Participate in Customer / Agency Audits and Inspections as required
- Participate in on-job training program for staff and provide guidance to team members as required
- Any other tasks as and when assigned by supervisor
**About You**:

- Diploma/Bachelor/Master/Doctoral Degree in Engineering/Science.
- Min. 5 to 7 years’ experience in the Validation / Quality unit in the Biopharmaceutical industry.
- Familiar with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, GAMP and ICHQ7)
- Good knowledge and experience of the practical and theoretical requirement of validation program in GMP facility
- Good interpersonal skills
- Effective Communicator (oral and written)
- Exhibit good quality decision making traits
- Meticulous and Systematic
- Analytical Mind
- Team player who can operate independently, with strong focus on safety, quality and timelines

Contract length: 12 months (Option to extend pending performance and business needs)

**Job Type**: Contract

Location : Tuas

Contract length: 12 months

**Salary**: $5,000.00 - $9,000.00 per month

COVID-19 considerations:
All staff to observe MOH regulations and practices.

**Education**:

- Bachelor's or equivalent (preferred)
**Experience**:

- Biopharmaceutical Industry: 5 years (preferred)

  • Senior Validation Engineer

    2 weeks ago

    Singapore NUSANTARA PRIME CONSULTING PTE. LTD. Full time

    **Purpose**:Support equipment qualification, system qualification, and cleaning validation. **Responsibilities**: - Develop, review and/or approve validation lifecycle document and protocols/reports in accordance with relevant policies, standards, procedures and guidelines, and completed in a timely fashion. - Lead project validation activities, and...

  • Senior Validation Engineer

    2 weeks ago

    Singapore PSC BIOTECH PTE. LTD. Full time

    Completing work assignments as specified by the Validation Project Manager - Providing timely updates to the Validation Project Manager - Adhering to the proper site safety practices; wearing adequate safety equipment when required - Completing timesheets and expense reports in a timely manner - Working in a biotech/pharmaceutical environment as a...

  • Senior Validation Engineer

    2 weeks ago

    Singapore PQE Group Full time

    Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries ?PQE Group has been at the forefront of these industries since 1998 , with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas. Due to our constant growth, we are looking for a Senior Validation Engineer to...

  • Junior Validation Engineer

    4 days ago

    Singapore PQE Group Full time

    Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries ?PQE Group has been at the forefront of these industries since 1998 , with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas . Due to our constant growth, we are looking for a Junior Validation Engineer to...

  • Engineer Validation

    2 weeks ago

    Singapore Manufacturing & Operations Full time

    Job Description The Validation Engineer is responsible for ensuring that medical devices and manufacturing processes meet required quality standards and regulatory requirements. It includes leading and/or executing validation activities, including equipment, process, test method, and software validation, to ensure that products are manufactured consistently...

  • Engineer (Validation)

    5 days ago

    Singapore Lonza Biologics Porriño SLU Full time

    Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...

  • Validation Engineer

    2 weeks ago

    Singapore COALESCE MANAGEMENT CONSULTING PTE. LIMITED Full time

    **Position: Validation Engineer** We are Coalesce Management Consulting - a community of people with a strong passion for excellence. We deliver bespoke project solutions within the Life Science and Technology sectors through our community of high-calibre industry specialists. We are currently expanding our team and are looking for a Validation Engineer to...

  • Senior Staff Validation Engineer

    2 weeks ago

    Singapore Marvell Full time

    About Marvell At Marvell, we believe that infrastructure powers progress. That execution is as essential as innovation. That better collaboration builds better technology. Trusted by the world’s leading technology companies for 25 years, we move, store, process and secure the world’s data with semiconductor solutions designed for our customers’...

  • HIG HBM PE Senior Component Validation Engineer

    2 days ago

    Singapore Micron Technology Full time

    HIG HBM PE Senior Component Validation Engineer Join to apply for the HIG HBM PE Senior Component Validation Engineer role at Micron Technology HIG HBM PE Senior Component Validation Engineer 1 day ago Be among the first 25 applicants Join to apply for the HIG HBM PE Senior Component Validation Engineer role at Micron Technology Our vision is to transform...

  • Validation Engineer

    4 days ago

    Singapore ANTER CONSULTING PTE. LTD. Full time $90,000 - $120,000 per year

    About the RoleWe are looking for an experienced Validation Engineer to support the Commissioning, Qualification, and Validation (CQV) activities for an ongoing fill-finish expansion project. This mid-level role will involve executing qualification protocols, supporting commissioning activities, and ensuring all systems (utility and process equipment) meet...