Validation Lead

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 patient. Amgen therapeutics has changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines in both large and small molecules, Amgen remains committed to advancing science to dramatically improve people’s lives.

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 lifecycle 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 lifecycle 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
- 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.
- Drive Operational Excellence initiatives within validation work space.

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 strategy and methodology, cleaning characterization/inactivation reports, acceptance limits reports) for new product introduction
- Execute, lead and drive cleaning development, 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 Lifecycle Maintenance
- Ensure maintenance of site validation master plan and routine monitoring of validation status/regulatory compliance of equipment and system

All listed tasks and responsibilities are deemed as essential functions to this full-time position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.

**Basic Qualifications**
- Master’s degree in Engineering and 4 years of experience in pharmaceutical company or GMP environment OR
- Bachelor’s degree in Engineering and 6 years of experience in pharmaceutical company or GMP environment OR
- Diploma in Engineering, and 8 years of experience in 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 small molecule cleaning and manufacturing unit operations would be preferred
- Experience in reviewing/approving validation protocols and rep