Principal Validation Engineer

7 days ago

New Albany, Ohio, United States Amgen Full time

**HOW MIGHT YOU DEFY IMAGINATION?**

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Principal Validation Engineer

**Live**

**What you will do**

Lets do this. Lets change the world. In this role you will lead and coordinate Packaging Process Validation, Packaging Equipment C&Q/Characterization, Packaging Components Qualifications, Commercial Support, Process Monitoring, Deviations/CAPAs and Lab Operation for Combination Products.

**Key Responsibilities**

+ Ensure initiation/preparation and closeout of all validation related documents and change controls

+ Overseen development of Validation Plan and Strategy

+ Manage C&Q/Characterization and Validation execution

+ Align Strategy and responses for internal audits on Packaging Equipments validation Protocol and Plans

+ Act as a Validation Lead for all validation projects

+ Coordinate business activities and assign business tasks to support executions

+ Evaluate proposed changes to validated systems and recommend level of validation required

+ Led all aspects of project management activities for validation projects process within the scope of an overall system project

+ Assist with the development of system requirements and specifications to ensure requirements are testable and met

+ Implement or coordinate the execution of validation plans and validation documents;

+ Coach the implementation teams in the proper execution of validation documents;

+ Preapprove test scripts before they are executed and approve after they have been executed.

**Win**

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek will possess these qualifications.

**Basic Qualifications:**

Doctorate Engineer or Science degree & 2 years of directly related experience

OR

Masters Engineer or Science degree & 4 years of directly related experience

OR

Bachelors Engineer or Science degree & 6 years of directly related experience

Or

Associates degree and 10 years of directly related experience

Or

High school diploma / GED and 12 years of directly related experience

**Preferred Qualifications:**

+ 6 + years biotech or pharmaceutical industry experience

+ Validation experience on Pharmaceutical Packaging Process and Equipment Validation with focus on Combination Products

+ Able to facilitate and influence senior collaborators and partners

+ Able to successfully manage workload and timelines

+ Ability to negotiate a strategic position after taking feedback from multiple sources

+ Strong project management, problem-solving, and analytical skills

+ Collaborates and communicates well with others, able to balance divergent inputs from various partners and drive issue resolution

+ Ability to operate in a matrixed environment with site, functional, and executive leadership

+ Experience driving decision making by using DAI principles

**Thrive**

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising 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 including:

+ 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 and bi-annual company-wide shutdowns

+ Flexible work models, including remote work arrangements, where possible

**Apply now**

**for a career that defies imagination**

Objects in your future are closer than they appear. Join us.

****

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 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.

  • Principal Validation Engineer

    7 days ago

    New Albany, Ohio, United States Amgen Full time

    Principal Validation Engineer page is loaded Principal Validation Engineer Apply remote type On Site locations US - Ohio - New Albany time type Full time posted on Posted 2 Days Ago job requisition id R Career Category Engineering Job Description HOW MIGHT YOU DEFY IMAGINATION?If you feel like you're part of something bigger, it's because you are. At Amgen,...

  • Engineering Tech Lead

    7 days ago

    New Albany, Ohio, United States Validation & Engineering Group Inc. Full time

    Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual...

  • Packaging Engineer

    1 week ago

    New Albany, Ohio, United States Infotree Global Solutions Full time

    Onsite - New Albany 100% Ideally candidate would do 5% domestic travel - once a quarter to vendor sites. Ideal candidate: Packaging education and experience is a requirement. AutoCAD and illustrator software requirements. 4 YOE in pharmaceutical packaging. Minimum of a bachelors in packaging. Open relocate on their own. What you will do This position...

  • Mechanical Equipment Engineer

    7 days ago

    New Albany, Ohio, United States ACL Digital Full time

    Associate Technical Engineer Long Term Contract (2 years) Location: New Albany, Ohio, 43054 In this role you will provide technical engineering support on all system/equipment optimization strategies, upgrades, replacements, repairs, and modifications. You will evaluate and determine if process equipment maintenance, and technical cleaning systems are...

  • Automation Engineer

    1 week ago

    New Albany, Ohio, United States TriMas Corporation Full time

    Automation Engineer Company:Rieke LLC Primary Location:8200 Innovation Campus Way West, New Albany, OH 43054 USA Employment Type: Salaried | Full-Time Function:Engineering Equal Opportunity Employer Minorities/Women/Veterans/Disabled Main Duties & Responsibilities The Manufacturing Automation Engineer, working with ourglobal new product launch teams, will...

  • Associate Controls Engineer

    1 week ago

    New Albany, Ohio, United States SSI People Full time

    Day shift- 630 am - 3 pm for first 3-6 months then will transition to 2nd shift 6 pm- 6 am (a few days on few days off) Associate Mfg Systems Engineer: Description: Based in New Albany, Ohio, the site of Amgens new advanced product assembly and packaging plant. In this role you will provide technical engineering support on all system/equipment optimization...

  • Associate Mfg Systems Engineer

    1 week ago

    New Albany, Ohio, United States Aditi Consulting Full time

    Summary:In this role you will provide technical engineering support on all system/equipment optimization strategies, upgrades, replacements, and modifications. You will evaluate and determine if utility systems, process maintenance, instrumentation/ calibration/electrical systems and technical cleaning systems are maintained in compliance with all applicable...

  • Senior Manager- Packaging Engineering

    1 week ago

    New Albany, Ohio, United States Amgen SA Full time

    HOW MIGHT YOU DEFY IMAGINATION?If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better...

  • Packaging Engineer

    1 week ago

    New Albany, Ohio, United States Michael Foods Full time

    Business Unit Overview For 75 years, Bob Evans Farms has delivered delicious, quick-to-table, farm-inspired food that makes mealtime a little bit easier and a lot more delicious. We're proud to be the #1-selling refrigerated dinner sides, including many varieties of feel-good favorites such as mashed potatoes and macaroni & cheese. We're also a leading...

  • Designer Associate

    1 week ago

    New Albany, Ohio, United States BHI Energy Full time

    Details: Designer AssociatePosition Summary: Perform daily work activities with direct to moderate supervision. Work activities to be performed include: computer aided drafting to prepare maps, sketches, schematics and other engineering related drawings. The position includes associated clerical work to properly manage and document the work activities...

  • Associate Mfg Systems Engineer

    7 days ago

    New Albany, Ohio, United States US Tech Solutions Full time

    Top 3 Must Have Skill Sets: PLC Experience Electrical Troubleshooting Technical Writing CapabilityIMPORTANT: The work schedule for this role will be a first shift (Monday through Friday, approximately 6:30 am to 3 pm) and then move to an off shift schedule (6pm-6am). As the facility moves into operation, the successful incumbent will be expected to join a...

  • Business/Professional

    7 days ago

    New Albany, Ohio, United States BHI Energy Full time

    Business/Professional New Albany, OH Posted: 1/17/2024 Job Description Job ID#: 344513 Job Category: Business/Professional Duration: 1 year About BHI Energy BHI Energy is a broad umbrella organization with a complete service offering that covers all facets of Power Generation through the entire Electrical Delivery system. For over 40 years, our diverse...

  • Commissioning Engineer, AMER-Central ACx

    1 week ago

    New Albany, Ohio, United States Amazon Full time

    Are you experienced in Critical Infrastructure Commissioning and looking for a fast paced and cutting-edge environment to work in? As a Data Center Commissioning Engineer (CxE), you will be part of highly creative, efficient team tasked with tackling fascinating and challenging problems building and supporting the operations of Amazon owned data centers. The...

  • Electrical Engineering Quality Assurance Engineer

    1 week ago

    New Straitsville, Ohio, United States NovaWorks Full time

    Job OfferAs a family-owned company, we develop, produce, and distribute top-of-the-line surgical technology worldwide. With our forward-thinking management, we drive medical progress and uphold values such as trust, respect, and openness. This is the foundation of our success. *For our location in Tübingen, we are looking for an * *Electrical Engineering...

  • Project Scheduler, Sr

    1 week ago

    New Albany, Ohio, United States BHI Energy Full time

    Position Summary: Support the development and analysis of project and maintenance outage schedules using Primavera Project Planner Enterprise (P6) through technical guidance, training, and verification. When applicable, administer, maintain security, reporting, maintenance, and daily operation of Primavera Project Planner Enterprise Software, scheduling...

  • Hardware in Loop Systems Engineer

    1 week ago

    New Bremen, Ohio, United States Crown Equipment Full time

    Hardware in Loop (HIL) Systems Engineer (Indefinite US Work Authorization Required) Location New Bremen, OH, US, 45869 Company Description: Crown Equipment Corporation is one of the world's largest material handling companies, with a reputation for award-winning product design, advanced engineering and technology, and superior after-sale service. Crown...

  • mechanical Engineering Co-op

    1 month ago

    New Bremen, Ohio, United States Crown Equipment Corporation Full time

    Company Description:Crown Equipment Corporation is a leading innovator in world-class forklift and material handling equipment and technology. As one of the world's largest lift truck manufacturers, we are committed to providing the customer with the safest, most efficient and ergonomic lift truck possible to lower their total cost of ownership.Job...

  • Field Engineer

    1 month ago

    New Bremen, Ohio, United States Crown Equipment Corporation Full time

    Who We Are:Be part of an innovative, technology-driven and growing organizationAs one of the world's largest lift truck manufacturers, our innovative and diverse workforce is dedicated to defining the future of the material handling industry. We have a reputation for award-winning product design, advanced engineering and technology and commitment to...

  • Field Engineer

    3 weeks ago

    New Bremen, Ohio, United States Crown Equipment Corporation Full time

    Who We Are:Be part of an innovative, technology-driven and growing organizationAs one of the world's largest lift truck manufacturers, our innovative and diverse workforce is dedicated to defining the future of the material handling industry. We have a reputation for award-winning product design, advanced engineering and technology and commitment to...

  • Health Services Administrator

    1 week ago

    New Albany, Ohio, United States Bechtel Corporation Full time

    **Requisition ID: 276879** + **Relocation Authorized: None** + **Telework Type: Full-Time Office/Project** + **Work Location: New Albany, OH** # Extraordinary teams building inspiring projects: Since 1898, we have helped customers complete more than 25,000 projects in 160 countries on all seven continents that have created jobs, grown economies, improved the...