Career Category

Job Description

Role Description

This role will serve as a technical lead/subject matter expert (SME) and lead full time Amgen staff members and/or contractors to provide validation services for systems associated with the manufacture of biologics at Amgen Singapore Manufacturing (ASM) facilities.

This position will establish compliant validation strategies and procedures to align with Amgen operating standards and regulatory expectations. Accountable for creating/monitoring validation goals and completing milestones related to deliverables for commissioning, qualification, cleaning validation and validation maintenance. 

Experience in employing a risk-based and science-based approach to the specification, design and verification of manufacturing systems and equipment is required. This position will ensure that all staff working on validation are adequately trained and skilled to perform their duties.

Responsibilities:

General

• Responsible for providing technical support and leading team of validation engineers to provide technical support for commissioning, qualification, cleaning validation and validation maintenance in ASM

• Establish validation strategies and procedures to align with Amgen operating standards and regulatory expectations

• Coordinate actions with Manufacturing, Engineering, Quality, Supply Chain, and Process Development to ensure that the overall Amgen validation requirements are met

• Provide SME support & represent validation for filings, audits and regulatory inspections

• Close interactions with Amgen’s corporate validation network to influence strategic management of the validation programs

• May be required to own or provide subject matter expertise to SOP, deviations, corrective/preventive actions and change controls

• Escalate significant validation related issues to operation management in a timely manner

• Lead and support site/network validated driven continuous improvement initiatives/activities

• Mentor and coach cross functional team members on validation technical knowledge

Cleaning Validation

• Responsible for deliverables related to cleaning validation

• Responsible for providing cleaning validation expertise including generation/review/approval of cleaning related documents (e.g. cleaning characterization/inactivation reports, acceptance limits reports) for new product introduction

• Execute, lead and drive cleaning verification/validation activities including change control, training, generation/review/approval of protocols and reports

Commissioning/Qualification

• Provide oversight of validation tasks and advice to clients on equipment validation for manufacturing process equipment, supply chain facilities and analytical laboratories

• Technical execution of validation tasks associated with Controlled Temperature Chamber (CTC). The chambers will include commercial off the shelf (COTS) units but may include other more complex validations as necessary

• Collaborate with project leads with direct accountability for project milestones related to validation deliverables for commissioning and qualification. Projects can range from equipment upgrades to large-scale capital projects and facility construction

Validation Maintenance

• Ensure maintenance of site validation master plan and routine monitoring of validation status/regulatory compliance of equipment and system

Basic Qualifications

• Master’s degree in Engineering & 4 years of experience in pharmaceutical company or GMP environment OR

• Bachelor’s degree in Engineering & 6 years of experience in a pharmaceutical company or GMP environment OR

• Undergraduate diploma in Engineering & 8 years of experience in a pharmaceutical company or GMP environment

Preferred Qualifications

• Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff

• Extensive experience in equipment qualification & cleaning validation (including establishing validation strategies and procedures) for biologics facility would be preferred

• Strong knowledge and understanding of biologics manufacturing unit operations would be preferred

• Experience in reviewing/approving validation protocols and reports in support of facility/equipment commissioning, qualification, and change management

• Experience in technical execution of validation tasks associated with cleaning validation, steaming validation (including autoclaves) and controlled temperature chambers (CTC)

• Experience in maintaining the validated state through continued verification

• Experience in resolving complex validation related investigations and well verse in root cause analysis tools

• Experience in supporting regulatory submissions, response to submission questions, pre-approval/biennial inspections, and observational response plans

• Experience in training/coaching of junior engineers and managing validation resources to meet schedules

• Self-directed and ability to work independently in a fast paced/dynamic work environment

• Good time management skill, great attention to detail, ability to multi-task across concurrent projects