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Validation Engineer West Greenwich, RI
Job Location:
Job Location:
West Greenwich, RI - USA
Monthly Salary:
$ 116187 - 116187
Monthly Salary:
Posted:
21 August 2026 (30+ days ago)
Posted:
Application Deadline:
18 November 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
ATTENTION MILITARY AFFILIATED JOB SEEKERS- Our organization works with partner companies to source qualified talent for their open roles. The following position is available toVeterans Transitioning Military National Guard and Reserve Members Military Spouses Wounded Warriors and their Caregivers. If you have the required skill set education requirements and experience please click the submit button and follow the next steps. Unless specifically stated otherwise this role is On-Site at the location detailed in the job post.
Validation Engineer
What you will do
Lets do this. Lets change the 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 Islands Manufacturing Facilities (AR5 and AR30) and managing the lifecycle of ARIs 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 you
We 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.
What you will do
Lets do this. Lets change the 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 Islands Manufacturing Facilities (AR5 and AR30) and managing the lifecycle of ARIs 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 you
We 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.
Additional Qualifications/Responsibilities
What we expect of you
We 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
Associates degree and 6 years of Manufacturing and Operations experience OR
Bachelors degree and 2 years of Manufacturing and Operations experience OR
Masters 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 us
As 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 well 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.
Salary Range
85878.05USD -116187.95USDRequired Experience:
IC
About Company
VetJobs & Military Spouse Jobs works with our employer partners to source, screen, and move qualified talent to the desktops of the Hiring Managers. Application is a two-step process, so please be patient with the team. When you submit to a position on our site your information will ... View more
