Job Description

Career Category Engineering



Validation Lead

Amgen Singapore Manufacturing

HOW MIGHT YOU DEFY IMAGINATION?

Amgen is one of the world\xe2\x80\x99s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring a Validation Lead in Amgen Singapore Manufacturing.

Validation Lead

Live

What you will do

This role will include a significant amount of small molecule exposure and serve as a technical lead/domain expert (SME) and lead full time Amgen staff members and/or contractors to provide validation services for systems associated with the manufacturing plants at Amgen Singapore Manufacturing (ASM) facilities. This role requires a strong knowledge and understanding of pharmaceutical process and equipment unit operations.

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 work 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\xe2\x80\x99s corporate validation network to influence strategic management of the validation programs

• Required to own or provide domain expertise to SOP, deviations, corrective/preventive actions, validation schedule and change controls validation impact assessments

• Call out validation related issues to operation management in a timely manner

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

• Mentor and coach multi-functional team members on validation technical knowledge.

• Drive Operational Excellence initiatives within validation work space.

Cleaning Validation

• Responsible for work you\'re doing 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

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

• 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 work you\'re doing 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.

Win

What we expect of you

Qualifications

• Doctorate Degree OR
• Master\xe2\x80\x99s degree in Engineering and 2 years of experience in pharmaceutical company or GMP environment OR
• Bachelor\xe2\x80\x99s degree in Engineering and 4 years of experience in pharmaceutical company or GMP environment OR
• Diploma in Engineering, and 8 years of experience in pharmaceutical company or GMP environment

• 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 pharmaceutical 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 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 including explaining validation matters to auditors.
• 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

Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates\xe2\x80\x99 professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Your selection for this role will may be subject to fulfilling the medical requirements of this job scope. If so, you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company.

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

.

Amgen