Validation Engineer

Akkodis; Princeton (NJ); Remote; USD 100,000 - 125,000; Full time

Job summary

An innovative firm is seeking a Validation Engineer to support supplier process validations for sterile barrier packaging. This contract role emphasizes collaboration with suppliers to ensure compliance with regulatory standards, including FDA and ISO. The successful candidate will possess extensive experience in process validation and a strong understanding of sterile barrier packaging materials. This position offers the opportunity to make a significant impact on quality assurance in the medical device and pharmaceutical manufacturing sectors. If you are passionate about ensuring product integrity and compliance, this role is an exciting opportunity for you.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Short-term Disability

401K Plan

Commuter Benefits

Paid Sick Leave

Holiday Pay

Qualifications

• 8+ years of experience in process validation in regulated industries.
• Strong understanding of sterile barrier packaging and manufacturing processes.

Responsibilities

• Guide supplier process validations for sterile barrier packaging.
• Ensure compliance with FDA and ISO standards during validations.
• Lead technical discussions with suppliers to resolve validation issues.

Skills

Process Validation (IQ/OQ/PQ)

Analytical Skills

Regulatory Standards (FDA, ISO 13485)

Collaboration Skills

Education

Degree in Mechanical Engineering

Degree in Industrial Engineering

Degree in Sciences

Tools

Technical Drawings

Risk Management Principles

Job description

Akkodis is seeking a Validation Engineer for a 6+ months Contract position with a client located in remote location.

Pay Range: $44/hr. - $52/hr. (The rate may be negotiable based on experience, education, geographic location, and other factors.)

Job Description:

SUMMARY DESCRIPTION

This contract position focuses on supporting and overseeing supplier process validations specifically for sterile barrier packaging material manufacturing processes. This role requires expertise in process validation (IQ/OQ/PQ) and a demonstrated ability to guide suppliers in meeting regulatory and company standards.

The candidate will act as the primary liaison between the company and suppliers, ensuring effective communication and execution of process validation requirements, including CTQs verification and validation, risk assessments, and protocol reviews.

SUPERVISION RECEIVED

Reports to the Sr. Manager, Supplier Quality Development and Process Validation.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

The candidate will:

1. Perform, oversee, and guide supplier process validations (IQ/OQ/PQ) for sterile barrier packaging material manufacturing processes.
2. Ensure supplier process validation requirements (CTQs, drawings, specifications, risk levels, and protocols) are communicated, understood, and executed.
3. Collaborate with suppliers to review and approve validation documentation, including protocols and reports.
4. Provide hands-on support to suppliers during validation activities, ensuring compliance with regulatory standards (FDA, ISO 13485).
5. Lead technical discussions with suppliers to address validation challenges and resolve issues.
6. Coordinate post-design verification activities, including updates to engineering drawings to reflect CTQs and associated risk levels.
7. Deliver progress updates to internal stakeholders, ensuring alignment with program timelines and quality standards.
8. Conduct focused process audits, where necessary, to evaluate supplier compliance with validation protocols.

DESIRED MINIMUM QUALIFICATIONS

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

Education:

1. Degree in Mechanical, Industrial Engineering or Sciences disciplines.
2. 8+ years of experience in process validation (IQ/OQ/PQ) within a regulated industry, preferably medical devices or pharmaceuticals.
3. Strong understanding of sterile barrier packaging materials and associated manufacturing processes.
4. Proficiency in FDA, ISO 13485, ISO 11607, and other applicable regulatory standards.
5. Demonstrated ability to work collaboratively with suppliers and cross-functional teams.
6. Strong analytical skills and experience using data to drive validation decisions.
7. Experience with technical drawings, CTQs, and risk management principles.

If you are interested in this Validation Engineer job in remote location, please contact Nitesh Kumar at [phone] or [e-mail].

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees with the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.akkodis.com/en/privacy-policy.

The Company will consider qualified applicants with arrest and conviction records by federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Manufacturing

Industries

Medical Equipment Manufacturing and Pharmaceutical Manufacturing