Remote CSV Engineer for MES Validation & GMP Compliance

Accenture PLC; United States; Remote; USD 90,000 - 130,000; Full time

Benefits offered by this job

Remote work options

Flexible hours

Birthday off

No dress code

Happy Hours

Life & health insurance

Employee assistance program

Meal allowance

Referral bonus

Performance bonus

Recognition points

Learning budget

Career development

Buddy program

Global project exposure

Dynamic tech environment

Job summary

Accenture is seeking a Manufacturing & Operations professional focused on CSV/compliance in the MES domain. You will coordinate validation activities, generate and sign off GMP documents, and support training and change management on international projects.

The role requires a bachelor’s degree in engineering, 3+ years in CSV/regulatory environments, and strong English communication. Work is remote with global teams and fast-paced tech delivery.

Qualifications

• Bachelor’s Degree in Engineering; Master’s Degree is a plus.
• Minimum of 3 years of CSV experience in a regulated environment.
• Familiar with FDA, EU regulations.
• Knowledge of GAMP 5 - 2nd Edition, Data Integrity and ERES.
• Experience with Manufacturing & Operations systems desirable.
• Experience in large multi-disciplinary teams.
• Excellent technical writing skills.
• Strong analytical, problem solving, planning, detail-oriented and interpersonal skills.
• Strong written and oral communication skills.
• Fluency in English is required.

Responsibilities

• Coordinating validation activities for Manufacturing & Operations systems.
• Generating, reviewing, signing off, coordinating & executing GMP documents (IQ/OQ/PQ, Validation Master Plan, etc.).
• Establishing internal and external training activities for the project.
• Supporting lifecycle activities including Change Management, Incident Management, and Periodic Review.

Skills

Excellent technical writing

Analytical thinking

Problem solving

Planning

Detail-oriented

Interpersonal skills

Written and verbal communication

English fluency

Education

Bachelor’s Degree in Engineering

Master’s Degree a plus

Tools

GAMP 5

Data Integrity

ERES requirements

Job description

Accenture is seeking a Manufacturing & Operations professional focused on CSV/compliance in the MES domain. You will coordinate validation activities, generate and sign off GMP documents, and support training and change management on international projects.

The role requires a bachelor’s degree in engineering, 3+ years in CSV/regulatory environments, and strong English communication. Work is remote with global teams and fast-paced tech delivery.