Senior validation engineer - West Valley City, United States - Integra LifeSciences

Integra LifeSciences West Valley City, United States

4 weeks ago

Description

Changing lives. Building Careers.

Joining us is a chance for you to do important work that creates change and shapes the future of healthcare.

Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what's possible and making headway to help improve outcomes.

Responsibilities associated with this Senior Validation Engineer are directly associated with the introduction and launching of new or products and processes into a manufacturing facility.

The candidate must utilize problem solving techniques to resolve issues and conflict in order to meet the high-level goals set forth by the organization.

The candidate must be well organized and technically sound in understanding scientific rationale and justifying criterion from a quantitative standpoint.

The candidate must be familiar with process flow of a medical device organization, including the regulatory impact of change and the documentation path of a compliant process.

The candidate must possess technical writing experience in protocol generation and procedure generation. Some experience is required in master plan generation and the change control life cycle.

The candidate must be a team player who thrives in a cross functional environment, but also has the capability to work on their own to research, investigate and take decisions.

The qualified candidate must understand the concepts of risk management and the ability to identify and classify critical parameters within a production setting.

Qualified candidates must be experienced in one or more of the following areas of validation:
Equipment Qualification
Process Validation
Cleaning validation
Computer System Validation
Test Method Validation
Temperature Mapping Studies
To perform this job successfully, an individual must be able to perform each essential duty Satisfactorily:

Generation and execution of qualification/validation protocols including the generation, routing and approval of summary documentation.
Must be able to read and understand engineering or technical documentation (i.e drawings).
Work with project teams to develop DOEs and statistically sound tests for appropriate support of results.
Facilitate the execution of Process FMEA and other applicable risk analysis as deemed appropriate.
Complete test method validation, gauge R&R studies and other qualifications or studies to support product testing.
Scheduling coordination, material allocation and alignment of personnel in order to successfully complete validation assignments.
Develop statistically based sampling plans for in-process and final test sequencing.
Ensure that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements.
Support and address comments and suggestions associated with validation and engineering documentation.
Protocol, Deviation, and summary report generation and approval.
Change control, non-conformance and CAPA support.
Participate in FDA inspections, ISO certifications, surveillance audits and customer audits.

DESIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

Bachelors Degree in Engineering (Biomedical, mechanical, chemical) or Science.

2 to 5 years of experience in a Validation or Quality Assurance role for a medical device or pharmaceutical environment.

Demonstrates excellent organizational and communication skills.
Experience with qualifying medical device manufacturing equipment.
Results oriented with a strong focus on quality principles and conflict resolution.
Excellent technical writing skills with a thorough understanding of good documentation practice.
Experience with risk analysis (PFMEA)
Competent in tracking and updating schedules to provide upper management visibility of milestones and achievements.
Travel to other sites and offices domestically and internationally as required.
Ability to travel 25%.

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

This site is governed solely by applicable U.S. laws and governmental regulations.

If you'd like more information on your rights under the law, please see the following notices:

EEO Is the Law

|

EOE including Disability/Protected Veterans

Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the

ADA . If you have difficulty using our online system due to a disability and need an accommodation, please email us at or call us at

Integra - Employer Branding from Integra LifeSciences on Vimeo
#J-18808-Ljbffr

Validation Engineer

2 days ago

VTI Life Sciences San Francisco, United States

VTI Life Sciences (VTI) is seeking forward-thinking and ambitious engineers looking to accelerate their career in the pharmaceutical, biotechnology and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought lead ...
Validation Engineer

1 week ago

Inc. (Vti) San Francisco, United States

VTI Life Sciences (VTI) · is seeking forward-thinking and ambitious engineers looking to accelerate their career in the pharmaceutical, biotechnology and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought l ...
Senior Validation Engineer

2 days ago

CAI San Francisco, United States

Position Description: · The Validation Process Engineer develops documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment. These people are responsible for protocol writing and execution (field verification), and d ...
Senior Validation Engineer

4 days ago

CAI San Francisco, United States

Position Description: · The Validation Process Engineer develops documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment. These people are responsible for protocol writing and execution (field verification), and d ...
Senior Validation Engineer

18 hours ago

CAI San Francisco, United States

Position Description · The Validation Process Engineer develops documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment. These people are responsible for protocol writing and execution (field verification), and de ...
Audio Hardware Validation Engineer

2 days ago

CyberTec San Francisco, United States

Job Responsibilities: · Work with a small team of product engineers in developing optical designs & validation systems for AR applicationsSupport Audio design iterations, validations and simulations.Collaborate with cross-functional teams and suppliers in building prototypes and ...
Senior Validation Engineer

1 week ago

cagents San Francisco, United States

San Francisco, California / Southwest / Full Time · Position Description: · The Validation Process Engineer develops documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment. These people are responsible for protoc ...
Senior Validation Engineer

1 week ago

Hayden AI San Francisco, United States

About Us · At Hayden AI, we are on a mission to harness the power of artificial intelligence and machine learning to transform the way governments and businesses address real-world challenges. From optimizing bus lane and bus stop enforcement to pioneering digital twin modeling ...
Senior Validation Engineer

1 day ago

Katalyst Healthcares and Life Sciences Daly City, United States

Responsibilities:Write technical documents associated with projects. · Write engineering and design specifications (URS/FS/DS) and protocols (IQ/OQ/PQ/CSV) for facility and utility systems. · Perform (hands on) field execution of commissioning and/or validation documentation. · R ...
Validation Engineer

5 days ago

Katalyst HealthCares & Life Sciences South San Francisco, United States

Responsibilities: · Validation Strategy: Develop validation strategies aligned with regulatory standards. · Protocol Generation: Author and review validation protocols for processes and equipment. · Execution: Lead validation studies and analyze data, ensuring adherence to tim ...
Validation Engineer

1 week ago

BHO Tech Palo Alto, United States Full time

Job Description: · Validation Engineer · 2nd shift · Responsibilities · •Read and understand customer and product requirements. · •Work in a team environment to author and implement V&V protocols using peer review process. · •Design and conduct studies to validate performance c ...
Validation Engineer Staff 2

1 week ago

CAI San Francisco, United States

Position Description: The Validation Process Engineer develops documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment. These people are responsible for protocol writing and execution (field verification), and deve ...
Validation Engineer Senior 2

1 week ago

CAI San Francisco, United States

Position Description: · The Validation Process Engineer develops documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment. These people are responsible for protocol writing and execution (field verification), and de ...
validation engineer

1 day ago

Siliconcedars Hercules, United States

Product validation engineer for Analog/mixed signal IC design tools · We are currently looking for Product validation engineer for Analog/mixed signal IC design tools to join our team. · This position offers opportunity to examine, improve and innovate layout automation methodol ...
Validation Engineer

3 weeks ago

Fladger Assoc. Inc. San Mateo, United States

Job Description · Job DescriptionSanta Monica, CAContract Duration: 6-18 monthsRate: NegotiableResponsibilities: · Excellent employment opportunity for a Validation Engineer III in the Santa Monica, CA area. · Responsible for performing the validation of computer systems. · This ...
Validation Engineer

3 weeks ago

Zerova Technologies USA LLC Fremont, United States

Job Description · Job DescriptionSalary: $100,000-$150,000 · About Us: · Zerova Technologies designs and manufactures a complete line of electric vehicle (EV) charging solutions that power brands globally. Whether white-label or collaborative design partnerships, Zerova works clo ...
Validation Engineer

3 weeks ago

Fladger Assoc. Inc. Fremont, United States

Job Description · Job DescriptionFremont, CAContract Duration: 3-24 monthsRate: NegotiableResponsibilities: · Excellent employment opportunity for a Validation Engineer in the Fremont, CA area. · Manage and participate actively in all phases of qualification/validation for QC sys ...
Validation Engineer

1 week ago

Stark Associates LLC Palo Alto, United States

Job Description · Job DescriptionJob Role: Validation Engineer · Location: Palo Alto, CA · Contract: W2 · Job Description: · 6+ years of experience as a Validation Engineer. · 4+ years of experience with Labware LIMS, LabX, etc. · Plan, lead, and executed the validation efforts f ...
Validation Engineer

1 week ago

Rivian Palo Alto, United States

About Rivian · Rivian is on a mission to keep the world adventurous forever. This goes for the emissions-free Electric Adventure Vehicles we build, and the curious, courageous souls we seek to attract. · As a company, we constantly challenge what's possible, never simply accept ...
Validation Engineer

4 weeks ago

Fladger Assoc. Inc. Fremont, United States

Job Description · Job Description · Fremont, CA · Contract Duration: 3-24 months · Rate: Negotiable · Responsibilities: · Excellent employment opportunity for a Validation Engineer in the Fremont, CA area. · Manage and participate actively in all phases of · qualification/v ...

Senior validation engineer - West Valley City, United States - Integra LifeSciences

Description

Validation Engineer

Validation Engineer