Validation Lead

4 days ago

Singapore Wuxi Biologcis Full time

**Job Summary：**

Manage validation & qualification activities and system lifecycle from requirements analysis or product development to manufacturing, for equipment / facilities / utilities.

**Job content：**

1. Global Validation System Management (GENG Related, during project phase)

a) Establish and maintain the global validation system, including facilities and utilities qualification, manufacturing equipment qualification, cleaning validation, and shipping validation, etc. to maintain the consistence of validation strategy of various sites of WuXi Biologics

b) Track the update of regulations and guidance periodically, understand the current trends of pharmaceutical industry, Integrate the requirements from regulations, industry good practice (Such as ISPE guidance, PDA technical report), align with QA and other function teams to adjust the company-level validation strategy

c) Develop validation management tools for optimizing C&Q projects is better

2. C&Q (Singapore Project & Site)

d) Serve as C&Q leader and as SME for C&Q of equipment, facility and utility, as well as PPQ, Cleaning Validation, Shipping Validation, providing strategic guidance and knowledge to Singapore facilities

e) Develop and update site validation SOPs

f) Draft C&Q VMP and project schedule, review C&Q deliverables and manage C&Q activities, coordinate internal and external resource to solve the C&Q issues

g) Track the C&Q schedule and ensure adherence to schedule

h) Lead resolution of validation variance / issues in a timely and compliant manner

i) Ensure compliance with appropriate regulatory requirement and construction code

j) Ensure qualification status of site through re-qualification program and change control system

k) Support engineering related audit/visit by clients and regulatory authorities

l) Perform lesson learnt to share experiences and implement best practices;
m) Provide training and guidance on SOP and skills to team including vendors.

n) Lead the team to support authority inspections and client audits.

o) Responsible for validation team building, training and improving the team’s capability.

**Requirements：**

1.Bachelor degree or above, in Chemical Engineer, Biological Engineering or Pharmacy.

2. Demonstrated experience in validation or QA related work experience in cGMP environment (8 years as a guide)

3. Demonstrated experience in team management and development experience (3 years as a guide)

4. Demonstrated experience in audits by EMA, FDA and other international authorities is preferred

5. Familiar with pharmaceutical production process, cleaning process and sterilization.

6. At least skilled in two aspects of C&Q, cleaning validation, shipping validation and CSV

7. In depth knowledge and experience of regulatory requirements and industry standards (21 CFR Part 11/210/211, EU GMP, GAMP 5, ICH Q9/Q10; ISPE Baseline Guides, and PDA TRs.)

8. Project management skills;
9. People management skills

10.Good understanding of Quality System, EHS.

11. Strong collaboration, self-motivation, communication, problem-solving and influence skills;
12.Fluent in written and verbal English.

**Salary**: $10,000.00 - $17,000.00 per month

  • Validation Lead

    2 weeks ago

    Singapore Amgen Full time

    Validation Lead GCF Grade Level: 05 Site: Amgen Singapore Manufacturing (ASM) **Role Description** Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to...

  • Validation Engineering Lead

    1 week ago

    Singapore Micron Full time

    **Our vision is to transform how the world uses information to enrich life for all. **Join an inclusive team passionate about one thing: using their expertise in the relentless pursuit of innovation for customers and partners. The solutions we build help make everything from virtual reality experiences to breakthroughs in neural networks possible. We do it...

  • Engineer Validation

    2 days 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...

  • Manager, Ssd Validation

    1 week ago

    Central Singapore Emprego SG Full time

    **Location** - Singapore, Central Singapore**Job Type** - Full Time**Salary** - $6,000 - $11,000 Per Month**Date Posted** - 54 minutes agoAdditional Details **Job ID** - 106545**Job Views** - 1Roles & Responsibilities As a manager in the SSD Product Validation team, you will lead a forward thinking team that solves complex problems, responsible for the...

  • Validation Engineer

    3 days ago

    Singapore PSC Biotech Corporation Full time

    Join to apply for the Validation Engineer role at PSC Biotech Corporation . Responsibilities include: Process RQs (SIP, Bulk Sterilization, Autoclave)Warehouse mapping Filtration skids Trending of Results Develop, review, and approve validation lifecycle documents, protocols, and reports in accordance with policies, standards, procedures, and guidelines,...

  • Senior Validation Engineer

    3 days 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...

  • Validation Specialist

    1 week ago

    Singapore beBeevalidation Full time $6,000

    Job Title: Validation SpecialistWe are seeking an experienced Validation Specialist to join our team. In this role, you will be responsible for ensuring the successful execution of validation functions for customer projects.Responsibilities:Assist in completing tasks on time with good quality.Drive and support project teams for projects requiring validation,...

  • Validation Engineer

    6 days ago

    Singapore NUSANTARA PRIME CONSULTING PTE LTD Full time

    This role is responsible for supporting validation activities including develop, support and implementation. In this role, the engineer must ensure qualification activities are performed in accordance with the company’s policies and procedures, and regulatory requirements **Responsibilities**: - Support equipment, facilities, utilities qualifications, -...

  • R&d - Lead Verification & Validation Engineer

    1 week ago

    Singapore SEARCH STAFFING SERVICES PTE. LTD. Full time

    Our client is a emergent brand name in the medtech sector. We are looking for like-minded individuals who are passionate to join them to develop their next generation of medical electronics. **Lead Verification & Validation Engineer** **(Medical Devices) **Responsibilities** - Work closely with the design team to ensure the product is designed with clear...

  • Validation Engineer

    2 weeks ago

    Singapore No deviation Pte Ltd Full time

    About No deviation At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful...