Validation & Engineering Group, Inc.

MV06-022326 Digital Project Engineer

Validation & Engineering Group, Inc.  •  Lebanon, IN (Hybrid)  •  1 month ago
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Job Description

Pinnaql is a trusted consulting partner to regulated life sciences companies, providing deep technical, validation, and quality expertise across every stage of the product lifecycle. We partner with pharmaceutical, biotech, and medical device organizations to navigate complexity, accelerate project timelines, and maintain a strong state of compliance and audit readiness.

We are currently seeking a Digital Plant Engineer who will work within an Automation Project Team on a capital project to define the project manufacturing system and data architecture for the individual project. The Digital Plant Engineer will have to interact with the Automation Project Team, Program Technical Office (PTO), and the End User.

This position can be based anywhere in the United States, but will require travel for onsite work in Indiana a minimum 2 weeks a month during the first 6 months of the project, and a minimum 1 week a month for the remaining project duration.


Role Responsibilities:

  • Join the dots between Business, Technology and Data architectures for the building
  • Represent the automation function in Digital Plant discussions and forums
  • Contribute to the Digital Strategy plan for the project
  • Contribute to Data Architecture for the project
  • Lead the data flow mapping activities for the project
  • Contribute to the delivery of the site level data infrastructure (e.g. Aveva PI, Logmate etc.)
  • Contribute to the overall automation philosophy for the program
  • Contribute to Digital Plant User cases
  • Communicate progress, issues, and needs to the Automation Project Manager
  • Provide technical consulting and support as a member of the Project automation team
  • Interface with other disciplines and stakeholders to ensure the Project deliverables meet business needs
  • Maintain compliance with training requirements

Role Requirements:

  • BS Engineering (or equivalent experience)
  • 7+ years’ experience in data strategy/architecture in API/bulk manufacturing Pharmaceutical Industry
  • Automation experience in the Pharmaceutical Industry (preferable in API/drug substance manufacturing)
  • Previous experience in the delivery of large Automation Projects in the Pharmaceutical Industry.
  • Preferable previous experience in DeltaV Batch DCS
  • Preferable, previous experience with MES systems
  • Preferable, previous experience with Aveva PI
  • Exceptional teamwork abilities
  • Strong knowledge of GMP’s, regulatory requirements and computer system validation principles
  • Excellent written and verbal communication skills for both technical and non-technical audiences

At Pinnaql, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Pinnaql is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

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Validation & Engineering Group, Inc.

About Validation & Engineering Group, Inc.

Validation & Engineering Group, Proudly serving our clients since 1997.

Our Mission states in part: "provide our clients with the best resources to meet their needs". In our search for the best talent, we are inclusive and do not discriminate. V&EG is proud to be an equal opportunity workplace and is an affirmative action employer.

Validation & Engineering Group provides world-class service and expertise to the pharmaceutical, medical device and biotechnology industries. We offer our clients: Validation, Control System Solutions, Instrumentation, Training, Equipment Rentals, and Regulatory Compliance Services to ensure adherence to Federal and European regulatory agencies. Our group had serve in solid dosages, liquids, creams, lyophilizers, and parenteral dosage.

Our agility in responding to our clients’ needs, access to the best pool of talent, and the combined experience and technical expertise of our resources make Validation & Engineering Group a leader in the pharmaceutical, medical devices, and biotechnology industries.

At Validation & Engineering Group we provide professional expertise in the areas of:

•Audit and Assessment

•Automated Process Control System Qualification

•Equipment and Facilities Qualification

•Facilities Start-Up and Commissioning

•GAP Analysis

•Information Systems Computer Validation

•Packaging and Process Analysis

•Process & Cleaning Validation

•Project Management

•Quality Systems

•Risk Based Approach

•Regulatory Compliance

•Standard Operating and Maintenance Procedures

•Training

•Utilities Support and Qualification

In addition we offer Equipment Rentals and training to your workforce such as: Temperature & Relative Humidity, Electrical, Process, Environmental, and. Analytical.

Our Offices:

Puerto Rico:

Centro Internacional de Mercadeo I 100 Carr. 165 Ste 703, Guaynabo, 00968 Puerto Rico

Phone: (787) 622-0996

United States:

2180 Satellite Blvd, Suite 400Duluth, Georgia 30097 United States

Phone: (770) 403-5802

Industry
Architecture & Engineering
Company Size
51-200 employees
Headquarters
Guaynabo, PR
Year Founded
1997
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