Validation Engineer Job Description template and pdf with duties [2024]

Job summary 1

We are looking for an outstanding Validation Engineer who will effectively lead quality related validation activities to support the Quality Management System. The end goal is to deliver high-quality validation and supporting documentation to Manufacturing Sites and Division Engineering Projects. This role requires strong technical, communication, interpersonal and organizational skills, and a solid understanding of the application of Regulatory, ISO standards and company policies, processes, procedures and guidelines. The successful candidate will be able to perform, plan, schedule and estimate discipline project costs including writing, updating and reviewing of engineering studies, user requirements, validation plans, qualification protocols and reports. Generate, input, route and review items for approval in the quality system.

Duties & Responsibilities 1

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Requirements & Skills 1

Bachelors’ degree (B.S.) in a Science related field (Engineering, Biology, Chemistry, other technical degree OR relevant combination of education or experience)
5+ years of related work experience in a medical device or other healthcare industry with strong technical competency in performing facility/utilities/equipment qualification, et al. validations
Must be familiar with good documentation practices (GDP) and cGMP environment
Strong validation experience in the following areas: Facilities (HVAC/ Environmental Monitoring Program), Utilities (Water Systems), Equipment (Washers, Autoclaves and Fillers), Automated Process Controls, Purification and Compounding Manufacturing Processes, Analytical & Physical Test Methods, Statistical Sampling and Process Monitoring (SPC)
Has a history of completing successful cross-functional projects and driving positive, compliance outcomes
- Proficient using Microsoft Word, Excel and Outlook for reporting and email correspondence.
- Must be able to travel for extended periods averaging 1-2 weeks per month as required; Approximately 25% to 50% of the work may require domestic and/or international travel
- Candidate must be capable of working independently and/ or on project teams, adapting to a flexible work schedule, paying attention to detail, performing critical analysis of situations and providing recommendations.

Job summary 2

The Validation Engineer position is responsible for defining validation strategy and coordinating validation activities required to complete assigned validation projects in support of the operation of the Commercial Manufacturing Facility. An ideal candidate would have previous experience with the performance of such validation activities that include Equipment/Utility/Facility Qualification, Cleaning Validation, and Automation System Qualification across the entire validation lifecycle from Plan to Retire.

Duties & Responsibilities 2

Requirements & Skills 2

Bachelors degree (Life Science, Engineering, Biology, Biochemistry) - recommended
Minimum of 4 years (Validation Engineer E2) / 8 years (Sr. Validation Engineer E3) of direct validation experience and/or GMP operations experience with increasing levels of responsibility for a wide range of validation projects including validation of large scale biochemical manufacturing, utility and automation systems.
- Proficient / Thorough knowledge of validation principles, manufacturing processes, quality systems, engineering design fundamentals, regulatory agency expectations and industry trends.
- Strong technical writing, verbal communication, interpersonal and problem solving skills.
- Ability to work independently, organize and manage individual as well as lead larger scale projects.

Job summary 3

The Validation Engineer is part of a team of experienced engineers who are collaborating to ensure Company successfully delivers the latest technologies to our connected vehicles. This is a blossoming and innovative feature area that merges the latest technologies from the vehicle and cloud connectivity.

Duties & Responsibilities 3

Your responsibilities will focus on working with multi-functional development, integration, and validation teams to design and build simulation scripts. The objective will be to move tests from vehicle to a bench (Short Term) and from a bench to Math via virtualization (Long Term). To do this you will:
- Analyze and review current test cases that are being completed on a vehicle and will be responsible to identify and implement solutions to help perform same tests on a bench.
- Review test cases that are being completed on a bench and work with internal teams to help implement methods to move tests from bench to a fully virtual setup.
- Assist in leading the team throughout this transformation (going from physical to virtual) and take part in defining, designing, and delivering groundbreaking results to transform test methodologies at an accelerated pace.

Requirements & Skills 3

Bachelor's Degree in Engineering, Computer Science or Information Technology
Minimum 5+ years of experience in software development and/or validation experience
Experience with Intrepid and/or Vector CANoe tools/SW
Valid US Driver's License
- MS in Electrical Engineering or Computer Science
- Experience with Connected Infotainment feature validation
- Strong CAN simulation expertise with prior experience designing and developing CAN simulations

Job summary 4

As a Validation Engineer, you will serve as an experienced, individual contributor on projects and assignments that are complex in nature and that support and enhance product performance, durability, reliability, quality, and serviceability. You will plan, support, and direct machine validation activities occurring on Hydraulic Mining Shovels (HMS) working closely with our team and worldwide customer locations to support product development and continuous improvement activities.

Duties & Responsibilities 4

Requirements & Skills 4

Job summary 5

This position will provide quality support for the QC Chemistry and QC Microbiology Laboratories and will be responsible for the development and execution of protocols to support the Qualification of equipment and equipment-related systems utilized in Quality Control at Company in accordance with cGMP requirements. Technical writing skills are essential for summarizing qualification results and data for the release of equipment and systems for use within the QC Laboratories. The Validation Engineer is responsible for understanding the current regulatory requirements and guidance, especially as it pertains to the QC Laboratory.

Duties & Responsibilities 5

Requirements & Skills 5

Job summary 6

As the Validation Engineer, you will play a critical role in supporting and expanding the company's manufacturing and quality control processes while maintaining cGMP compliance. You enjoy working in a dynamic environment with a high degree of flexibility, have experience with development and validation of automated equipment and systems in a regulated facility, and a passion to work as a leader within multi-functional teams.

Duties & Responsibilities 6

Assist in development of specifications as they relate to the equipment system and intended use.
Participation and review of applicable acceptance testing.
Writing and executing test validation protocols and associated documents.
Maintaining procedures, policies, documents for validation activities.
- Review, understanding, and compliance with Invitae HIPAA Security policies and procedures.
- Safeguarding the privacy and security of protected health information and European Union personal data.
- Processing and handling of European Union personal data only as directed by Invitae for purposes of personalized molecular pathology.

Requirements & Skills 6

Minimum 5 years of validation experience within a regulated industry; in vitro diagnostics, medical device, or biotech preferred.
Bachelor's degree in an engineering or science field.
- Installation of MES software systems into various manufacturing environments.
- Additional experience with computer systems and/or test method validation is preferred, but not required.
- Use of Microsoft Office products, Smartsheet, and similar systems.

Job summary 7

The Validation Engineer has ownership over product integrity as it pertains to validation of conventional & electrified automotive powertrain systems under development. Translates technical requirements & customer expectations into optimized validation plans, defines test objectives & methods, supports test execution, analyzes results, & ultimately makes technical acceptance decisions. Serves as a specialist-level technical liaison between Company and its internal & external customers.

Duties & Responsibilities 7

Requirements & Skills 7

B.S. in Engineering (Mechanical Preferred)
5 Years of Experience in Testing Within a Powertrain and/or Related Area
Solid Functional/Product Knowledge, Ability to Train Others
Working Knowledge of Automotive Powertrains, Measurement Systems, and Testing Methodology
Proficient with Microsoft Office Software
- Familiarity with Data Acquisition Systems, Data Analysis, and Data Processing
- Ability to Interface with Cross-Functional Teams and all Levels of Personnel/Management
- Strong Problem Solving and Analytical Skills

Job summary 8

The Validation Engineer will be designated to support validations for a CGMP facility. The Validation Engineer will be responsible for assisting with executing Installation, Operation, Performance Qualification, Requalification and Revalidation protocols for manufacturing equipment, clean rooms, utilities and systems using established validation templates, standards and procedures. The Validation Engineer will write and execute protocols for assigned validations. The Validation Engineer will also assist in process and cleaning validations.

Duties & Responsibilities 8

Prepares protocols and reports for validation, requalification and revalidation work
Assists with coordination and execution of validation studies for equipment including autoclaves, glass washers, depyrogenation ovens, utility systems (purified water, WFI water, gas systems, clean steam), incubators, clean rooms, freezers, and cold rooms
Performs testing using standard concepts, practices and procedures of the CGMP process
- Prepares, reviews and summarizes equipment history files to assess the validated state of equipment
- Assist in process and cleaning validations as required.
- Participate in the review of Standard Operating Procedures (SOPs) for system projects

Requirements & Skills 8

The candidate must have previous validation experience in Pharmaceutical/Medical Device industry, be familiar with aseptic processing and clean room operations, be able to work independently, possess strong organizational skills, and have good written and verbal communication skills.
Minimum Associates/Bachelors degree with 1-3 years of experience in validating GMP systems.
- Candidate will be a highly motivated and creative individual with hands-on validation skills working under minimal supervision.
- A solid level of competency with Kaye Validator programming and calibration of thermocouples, validation of test equipment, and technical writing skills are preferred.
- Strong familiarity with Microsoft Office, Word, Excel, and PowerPoint is required.

Job summary 9

The Validation Engineer is primarily responsible for executing multiple projects, on both a large and small scale by performing the following:

Duties & Responsibilities 9

Support the development of new processes or troubleshoot existing ones.
Author, execute, or review Validation documents such as: Validation Project Plans, Validation Project Plan Reports, Validation Qualification Reports, Validation Qualification Protocols, Risk Management tools, Cleaning Calculations, Formulation Evaluations, and Deviation Handling.
- Schedules and executes validations/qualifications per Standard Operating Procedures (SOPs) and regulatory guidelines.
- Coordinates and communicates all testing with affected functional groups and evaluates test results.
- Oversee/Assist other Validation Engineers and/or Technicians and/or contractors with their assigned projects.

Requirements & Skills 9

A Minimum of Bachelors in Mechanical/ Electronics & Communication/ Industrial

Job summary 10

We are seeking a highly motivated Validation Engineer to support our site.

Duties & Responsibilities 10

Responsible for performing the validation of equipment, utility systems, facilities, processes and/or automation systems for projects. This includes developing validation master plans with minimum supervision, preparing protocols independently, analyzing test results, and preparing technical reports.
Contributes directly to the completion of validation projects through the development of validation schedules, master plans, validation protocols and reports for systems that may be complex in nature, to support clinical and commercial manufacturing.
Coordinates validation activities with, and seeks team supports from, Validation, Development, Manufacturing, Engineering, Quality, third Parties, and other groups on validation projects to ensure validation projects are carried out on time and on budget.
Coordinates the activities of assigned validation and contract personnel and ensures the quality of completed work.
- Reviews protocols, reports and data tables generated by peers and contract personnel.
- Represents the department on cross-functional project teams.
- As required, assists in preparation of regulatory submissions and presents validations in respective SME areas to regulatory authorities during routine internal and pre-approval inspections.

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