Department: VEG
Location: Carolina, 031
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
- Process Engineering Support
The scope requires someone who can independently support technical discussions, evaluate equipment solutions, participate in capital projects, understand C&Q expectations, and interact with multiple stakeholders.
The resource will provide technical support throughout the project lifecycle, including equipment assessment, capital project development, design review, installation support, verification activities, change controls, investigations, and continuous improvement initiatives.
Required Qualifications
- Bachelors degree in Engineering (Chemical, Mechanical, Biomedical, Industrial, or related engineering discipline).
- Advanced technical background in pharmaceutical manufacturing, process engineering, or equipment lifecycle management preferred.
- Minimum 5+ years of experience supporting engineering activities within the Life Science / Pharmaceutical / Biotechnology industry.
- Experience working in GMP-regulated manufacturing environments.
- Experience supporting equipment lifecycle activities, capital projects, process improvements, or manufacturing support initiatives.
Technical Competencies Required
Process Engineering
- Experience supporting manufacturing process engineering activities, including:
- Process improvements
- Equipment replacement projects
- Manufacturing support activities
- Technical assessments
- Problem-solving activities
- Ability to provide technical recommendations and evaluate engineering solutions.
- Experience supporting equipment assessments, replacement strategies, and Business Continuity Planning (BCP) activities.
Capital Projects / Equipment Implementation
- Experience supporting capital project execution, including:
- Development of project scopes
- Technical evaluations
- Equipment procurement support
- Review of vendor documentation
- Review of design drawings and technical specifications
- Installation support
- Experience reviewing engineering documents such as:
- Equipment datasheets
- Design drawings
- Process documentation
- Technical specifications
Commissioning & Qualification (C&Q) / Asset Delivery
- Knowledge of Commissioning, Qualification, and Validation (CQV) processes.
- Experience supporting equipment verification activities, including:
- User Requirements Specifications (URS)
- Design Reviews
- Verification Strategies
- Installation Verification (IV)
- Operational Verification (OV)
- Experience with electronic qualification systems; Kneat experience preferred.
Quality / Compliance / Documentation
- Experience supporting:
- Change Controls
- CAPA implementation
- SOP updates
- Engineering documentation revisions
- Technical assessments
- Ability to participate in investigations and problem-solving activities, including:
- Root Cause Analysis (RCA)
- FMEA / PFMEA
- Problem Analysis
- Strong understanding of GMP documentation practices.
Preferred Experience
- Experience supporting Fermentation and/or Purification manufacturing processes.
- Experience with pharmaceutical manufacturing equipment and utilities.
- Experience coordinating activities with:
- Manufacturing, Quality Assurance, Engineering, EHS, Vendors / Contractors
- Experience supporting field implementation activities and equipment installation projects.
Systems / Tools Knowledge Preferred
- Kneat qualification platform, Veeva Quality Docs, GECMS, GMARS, Microsoft Project / Excel / PowerPoint
Key Behavioral Competencies
- Strong technical problem-solving skills.
- Ability to work independently and manage multiple priorities.
- Strong communication skills with technical and non-technical stakeholders.
- Ability to provide clear project status updates, identify risks, and escalate issues.
- Comfortable working onsite as required.
At Validation & Engineering Group, 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.
Validation & Engineering Group 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.
