CSV Engineer

Accenture; 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

As Manufacturing & Operations, part of Accenture, we are working in the domain of Manufacturing Execution Systems (MES), which means that the solutions we are working on are directly impacting how factories around the world are managing their manufacturing processes.

What’s in it for you?

Work-Life Balance: Remote working model / Flexible hours / Birthday off / No dress code / Happy Hours

Health & Wellness: Life & Health Insurance / An Employee Assistance & Wellness Program

Financial Benefits: Meal allowance / Employee Referral Bonus Program / Performance bonus & promotion / Accenture Recognition Points

Professional Development: Learning budget / Personal career development with People Leads / Buddy Program

Work Environment : Working on international projects with a globally diverse team / A fast-paced technology environment

Key Responsibilities:

• Coordinating validation activities for the respective system, including but not limited to Manufacturing & Operations systems,
• Generating, reviewing, signing off, coordinating & executing various program & GMP related documents and protocols, including but not limited to the following: Validation Master Plan, Validation Plan, URS, FS/DS, Risk Assessment, Test Plan, Test Specifications (IQ/OQ/PQ), relevant Summary Reports and change control
• Establishing internal and external training activities for the project,
• Supporting operational life cycle activities wherever relevant, including the Impact assessment for the Change Management and Incident Management, Periodic Review, etc. and coordinating the maintenance of deliverables as required.
  

Required Qualifications

• Bachelor’s Degree in Engineering, Master’s Degree is a plus
• Preferably, minimum of 3 years of CSV experience in a quality and/or GMP/FDA regulated environment
• Being familiar with industry regulations, including but not limited to FDA, EU, etc.
• Having know-how on GAMP 5 - 2nd Edition, Data Integrity and ERES requirements
• Exposure to Manufacturing & Operations systems is highly desirable
• Previous experience working as part of a large, multi-disciplinary team
• Excellent technical writing skills
• Strong analytical, problem solving, planning, detail-oriented and interpersonal skills required
• Strong written and oral communication skills needed
• Fluency in English is a must

#GreatPlaceToWork

Accenture is a leading global professional services company that helps the world’s leading businesses, governments and other organizations build their digital core, optimize their operations, accelerate revenue growth and enhance citizen services—creating tangible value at speed and scale. We are a talent- and innovation-led company with approximately 791,000 people serving clients in more than 120 countries. Technology is at the core of change today, and we are one of the world’s leaders in helping drive that change, with strong ecosystem relationships. We combine our strength in technology and leadership in cloud, data and AI with unmatched industry experience, functional expertise and global delivery capability. Our broad range of services, solutions and assets across Strategy & Consulting, Technology, Operations, Industry X and Song, together with our culture of shared success and commitment to creating 360° value, enable us to help our clients reinvent and build trusted, lasting relationships. We measure our success by the 360° value we create for our clients, each other, our shareholders, partners and communities.

Visit us at www.accenture.com

Equal Employment Opportunity Statement

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