Career CategoryOperations
Job DescriptionValidation EngineerWhat you will doLet's do this. Let's change the world. In this vital role is within the Product Lifecycle Management organization at Amgen Rhode Island (ARI), a large-scale mammalian cell biotech manufacturing plant that produces multiple commercial and clinical products. The team is responsible for new product introductions (NPI), product re-introductions (PRI) to Amgen Rhode Island's Manufacturing Facilities (AR5 and AR30) and managing the lifecycle of ARI's product portfolio. The schedule for this position is Monday - Friday Admin Day Shift.
Responsibilities:- Support validation strategy and execute validation activities for manufacturing equipment, support equipment, and utilities, including validation planning, protocol development and execution, performance qualification, equipment release, and lifecycle documentation.
- Plan and coordinate and execute equipment and system qualification activities across a range of technologies, including CIP, SIP and autoclave systems, airflow visualization studies, benchtop equipment, and supporting utilities. Apply appropriate risk- and science-based approaches based on the system and intended use.
- Serve as the validation technical expert during project planning, equipment implementation, design reviews, and change control. Interpret engineering, automation, process, and equipment design documentation to determine validation requirements and appropriate testing approaches in accordance with established procedures and standards. Develop/author Validation plans
- Generate, review, and approve validation documentation and provide validation impact assessments for changes, projects, and equipment modifications.
- Investigate technical issues and develop solutions to validation challenges of moderate complexity.
- Execute and support cleaning validation and continued cleaning verification activities.
- Maintain site cleaning acceptance criteria, including calculating maximum allowable carryover (MAC) and providing scientific justification for acceptance criteria.
- Drive continuous improvement of validation programs, procedures, and execution practices, and develop or deliver training to manufacturing staff in support of validation activities.
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The adaptable professional we seek is a self-starter with these qualifications.
Basic Qualifications- High school diploma / GED and 8 years of Manufacturing and Operations experience OR
- Associate's degree and 6 years of Manufacturing and Operations experience OR
- Bachelor's degree and 2 years of Manufacturing and Operations experience OR
- Master's degree
Preferred Qualifications- Experience working in a GMP pharmaceutical or biotechnology manufacturing environment, with exposure to upstream and/or downstream operations.
- Hands-on validation experience with manufacturing equipment, facility systems, and utilities, including equipment qualification, sterilization/steaming, cleaning validation, and performance studies.
- Strong technical understanding of pharmaceutical/biotechnology unit operations and manufacturing equipment and processes.
- Ability to interpret engineering and automation documentation and translate equipment and process requirements into appropriate validation testing.
- Strong understanding of GMP requirements and applicable CFR/regulatory expectations, with the ability to interpret and apply regulatory principles to validation activities.
- Strong analytical and experimental design skills, with the ability to evaluate validation data and resolve technical issues.
- Strong technical writing skills, with the ability to prepare clear, accurate, and compliant validation documentation.
- Strong verbal communication and project coordination skills, with the ability to work effectively across manufacturing, engineering, automation, and quality functions.
- Ability to work independently under general direction, manage priorities, and recognize when additional technical or management direction is appropriate.
What you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.careers.amgen.comIn any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadlineAmgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
SponsorshipSponsorship for this role is not guaranteed.
