Senior Validation Engineer 1

Career Category

Job Description

Join Amgen's Mission to Serve Patients

At Amgen, our shared mission to serve patients living with serious illnesses drives everything we do. Every team member plays an important role in helping advance science and deliver medicines that make a meaningful difference for patients around the world.

Amgen fights the world's toughest diseases by harnessing the best of biology and technology. We draw on our scientific expertise to push beyond what is known today and help people live longer, fuller lives.

If you are energized by collaboration, continuous learning, and meaningful work, we invite you to join our team and help make an impact.

Senior Validation Engineer I

What you will do

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

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

• 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 workspace.

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

• 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.

What we expect of you

• Doctorate Degree

• Master’s degree in engineering and 2 years of experience in pharmaceutical company or GMP environment OR

• Bachelor’s 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

Your selection for this role will 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.

What you can expect of us

As we work to develop medicines for patients, we also invest in our people. Through competitive benefits, development opportunities, and a collaborative culture, we'll support your growth both professionally and personally.

Apply now and help transform the lives of patients while transforming your career.

careers.amgen.com

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values as we continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity Employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided 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 accommodation.