Validation Engineer

IntePros; Raynham (MA); On-site; USD 100,000 - 125,000; Full time

Job summary

An established industry player is seeking a Validation Engineer to support new product introductions and ensure compliance with FDA and ISO standards. This role involves collaborating across teams to deliver innovative manufacturing solutions, with a focus on process and equipment validation in a regulated environment. The ideal candidate will have a strong background in engineering and a passion for advancing manufacturing technologies. Join a forward-thinking company that values teamwork and offers opportunities for professional growth in the life sciences and engineering sectors.

Qualifications

• 2-4 years of experience in process and equipment validation required.
• Strong knowledge of GMP/ISO regulations and validation processes.

Responsibilities

• Support development and implementation of advanced manufacturing technologies.
• Document and execute equipment and process validations (IQ, OQ, PQ).

Skills

Process Validation

Technical Writing

Communication Skills

Team Collaboration

GMP/ISO Regulations

Statistical Data Analysis

Education

Bachelor’s Degree in Engineering

Tools

Minitab

Job description

This range is provided by IntePros. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$40.00/hr - $50.00/hr

Direct message the job poster from IntePros

Connecting Innovators with Life Sciences & Engineering Roles

Our client is looking for a Validation Engineer with 2–4 years of experience in process and equipment validation within a regulated manufacturing environment, with a strong preference for foundry or metal casting experience. The ideal candidate will support new product introductions, ensure compliance with FDA and ISO standards, and collaborate across teams to deliver manufacturing solutions from concept to qualification.

Responsibilities

• Support development and implementation of advanced manufacturing technologies to deliver new product introductions, site capacity expansion, and transformational projects within a regulated medical device manufacturing facility
• Development of specifications and requirements for new equipment that support manufacturing operation
• Support design for manufacturability of new product introduction projects from concept through end-to-end process qualification
• Effectively team and partner with other functional groups as your projects go from concept to qualification
• Responsible for completing engineering tasks in support of an overall project plan
• Document, author and execute equipment and process validations (IQ, OQ, PQ) on various types of manufacturing equipment processes
• Creation of manufacturing work instructions, specifications, bills, routes and travelers in support of new and existing products
• Interface with internal/external partners on technical issues, project timeline, and validation support
• Ensure compliance with all FDA, ISO, quality, safety and environmental regulations
• Assist in manufacturing process risk-assessment to guide efficient and prudent validation planning and execution

Qualifications:

Education

• A minimum of a Bachelor’s Degree in Engineering, Science, or related technical field

Require

• 2-4 years relevant engineering experience is required (4 year Engineering Degree required). (namely, process/equipment validation, process engineering, and operations/production support with emphasis on Foundry and/or Manufacturing/Machining)
• Working knowledge and strategy in drafting and executing process/equipment validations (IQ, OQ, PQ) is required
• Must have the ability to effectively deliver in a team-based manufacturing environment with minimal supervision is required
• Strong technical writing skills are required
• Experience in a regulated work environment is preferred (i.e.: Medical Device, Aerospace, Automotive)
• A thorough understanding of GMP/ISO regulations (ie: ISO 13485, ISO14971) and validation regulations
• Must have strong communication and interpersonal skills
• The ability to collaborate with all levels of management in a cross-functional team environment is required

Preferred

• Hands on experience with one or more of the following: metal casting processes, CNC machining processes, metal finishing processes, Gage R&R CNC equipment, plastic or wax injection, laser processing or production automation is preferred
• Must have strong communication and interpersonal skills with the ability to influence
• Knowledge of statistical data analysis tools (e.g. Minitab) preferred
• Basic knowledge of Geometric Dimensioning and Tolerancing (GD&T) is preferred

This is a 12+ month W2 assignment.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Industries

  Pharmaceutical Manufacturing

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