Principal Validation Engineer

Amgen; Singapore; On-site; SGD 200,000 - 280,000; Full time

Job summary

Amgen Singapore is seeking a Principal Validation Engineer to lead validation strategies for synthetic DS/API and biologic DP across CMOs and support tech transfer activities. The role focuses on compliant process validation and cleaning validation, with experience in FDP qualification as a plus.

Occasional JAPAC travel is required. The candidate will drive risk-based decisions, develop playbooks for audits, and oversee validation documentation in collaboration with global quality teams and

Qualifications

• Direct experience with validation of processes in synthetic drug substance manufacturing or aseptic DP filling.
• Experience with qualification/validation of packaging processes is a plus.
• Experience with tech transfer / NPI and process validation is required or desired.

Responsibilities

• Be an integral quality member of cross-functional contract manufacturing teams.
• Translate Amgen requirements into the CMO language.
• Identify and assess validation/quality risks to enable risk-based decisions.
• Validation document author/approver.
• Oversight of synthetic API manufacturing process validation and cleaning validation.
• Oversight of aseptic DP filling process validation and cleaning validation.
• Oversight of packaging process qualification, device and combination product qualifications.
• Determine sampling plans and acceptance criteria for packaging processes.
• Implement statistical methods to create risk-based sampling plans.
• Prepare materials for audits/inspections.
• Perform validation change control assessments.
• Review/approve validation deviations.

Skills

Validation engineering

Tech transfer

Quality systems

Process validation

Statistical sampling

Job description

Join Amgen’s Mission to Serve Patients

At Amgen, our shared mission to serve patients living with serious illnesses guides everything we do. By combining science, innovation, and collaboration, we work to address some of the world’s toughest diseases and improve the lives of millions of people worldwide.

Amgen harnesses the best of biology and technology to help make people’s lives easier, fuller, and longer. Every role contributes to that mission, creating meaningful opportunities to lead, innovate, and make a lasting impact.

If you’re motivated by complex challenges, strategic thinking, and the opportunity to influence outcomes, we encourage you to explore a career with Amgen.

Principal Validation Engineer

What you will do

In this role you will be serving patients through internal collaboration with Amgen’s global quality teams, manufacturing sites and external engagement with contract manufacturing organizations. You will make key contributions to fulfill Amgen’s mission of serving patients by ensuring supply of high-quality product produced at contract manufacturers to patients.

The Principal Validation Engineer will oversee validation strategies and documents related primarily to Synthetic Drug Substance (DS / API) and Biologic Aseptically Filled Drug Product (DP). Experience with Finished Drug Product (FDP) product would be considered a valuable additional skill but is not required. The principal validation engineer will serve on the core tech transfer team and will be responsible for ensuring compliant Process Validation and Cleaning Validation strategies at the synthetic DS and biologic DP contract manufacturing organizations (CMOs) site. For FDP sites, if applicable, the validation engineer will ensure a robust qualification strategy (eg., OQ, PQ, and/or PPQ ) is implemented at the CMO. The CMO sites will be located primarily in the JAPAC region (China, India and Japan) , but some occasional support in EU or North America, may be required.

Direct experience with validation of processes in synthetic drug substance manufacturing or aseptic drug product filling is required. Experience with qualification/validation of primary and secondary packaging processes, including device / combination products is highly desired, but not required. The candidate should have experience with tech transfer / NPI and be experienced with process validation and cleaning validation. Some experience and understanding of implementing statistical methods for determining appropriate sampling plans and acceptance criteria, based on level of risk, is beneficial. Prior experience with, or willingness to learn, other modalities, including biologic drug substances are also desired. The role will be located in Singapore and require occasional, in-frequent, travel to contract manufacturing locations in China, India or Japan. Candidates located in other JAPAC regions may be considered based on qualifications.

Roles & Responsibilities:

• Be an integral quality member of Amgen cross-functional contract manufacturing teams that includes but is not limited to operations, analytical science, process development, supply chain, etc. Project teams will include tech transfers, new product introductions, and ongoing validation maintenance activities.
• Translate Amgen requirements into the language of the CMO.
• Identify and assess validation/quality risks to enable risk-based decisions.
• Validation document author/approver.
• Oversight of synthetic API manufacturing process validation and cleaning validation.
• Oversight of aseptic DP filling process validation and cleaning validation, as well as aseptic processing and sterilization validation oversight (media fill, autoclave validation, EM)
• Oversight of packaging process qualification, device and combination product qualifications.
• Determine appropriate sample plans and acceptance criteria for primary and secondary packaging processes.
• Implement statistical methods to create risk-based sampling plans and acceptance criteria.
• Prepare materials/documents (playbooks) for topics to be presented during audits/inspections.
• Perform validation change control assessments.
• Review/approve validation deviations.