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:
- Design Lead/Design Project Manager
Responsibilities:
- Lead in the identification of the applicable Engineering Design Standards, Engineering Functional Standards, Engineering Specifications and Regulatory requirements and guidance (both internal and external).
- Be responsible for the overall design delivery for capital project(s).
- Coordinate all design for the Project Manager during all design phases of the project and be responsible in delivering the conceptual design review and basic design review.
- Direct the development of the design requirements.
- Assist in development and maintenance of the design schedule to meet the project needs.
- Participate in the selection of the A/E firms.
- Coordinate with A/E firms to develop earned value progress systems to measure progress by discipline (monitor work versus invoice amounts).
- Expedite design decisions and coordinate information flow between the design team and system owners.
- Be responsible for ensuring the design meets approved intent through interactions between the design firm, design specialists, engineering tech center disciplines, and end user/customer.
- Be responsible for design activities and governance, resolving design-related problems.
- Examine areas of inefficiency and develop strategies for improvement to direct the design team to meet or improve on the design hours plan.
- Assist in the development of standard operating procedures, project delivery work instructions, and/or best practices related to design/verification and ensure they remain current with industry best practices.
- Review and approve along with the respective Project Manager the key design project personnel (both internal and external resources).
- Work with Engineering Tech Center resources, local engineering resources, and other key project team technical/constructability resources to address and resolve design issues.
- Ensure replication is achieved during design when applicable.
- Support the Project Manager for value engineering exercises efforts to maximize project opportunities.
- Review design-related invoices prior to approval and participate in KPI reviews/assessments.
- Participate in the selection of the verification professional services.
- Accountable for the development of the Project Verification Plan, Traceability Matrix, and risk assessments (not necessary lead the execution).
- Coordinate verification for the Project Manager during the verification phase of the project.
- Accountable for the discrepancy tracking and management in the Verification phase.
Qualifications:
- BS in Engineering (Chemical or Mechanical preferred) or BA in Architecture
- Minimum of 5-years manufacturing and/or engineering experience in support of pharmaceutical or API (active pharmaceutical ingredient) networks
Additional Preferences:
- Pharmaceutical design, process or project engineer experience
- Strong project management skills
- Ability to effectively facilitate conflict to resolution
- Ability to influence all levels of the project and site personnel
- Understanding of the capital project delivery process, A/E design activities, and the understanding of the available Lilly technical resources (user reps, Engineering Tech Center resources, and design specialists)
- Demonstrated values that are consistent with the Lilly values
- Able to frame complex decisions/analyses, facilitate to a decision, and implement according to the plan
- Ability to create creditability and influence to align decision agreements between site(s), corporate engineering, A/E firm decision-makers, and stakeholders who have differing opinions
- Experience facilitating issue resolution, anticipating scope changes, and implementing projects safely with quality, speed and value
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.
Skills Required
- BS in Engineering (Chemical or Mechanical preferred) or BA in Architecture
- Minimum of 5 years manufacturing and/or engineering experience supporting pharmaceutical or API networks
- Experience developing Project Verification Plans, Traceability Matrices, and risk assessments
- Pharmaceutical design, process, or project engineering experience
- Strong project management skills, including schedule development and earned value progress coordination
- Ability to facilitate conflict resolution and influence stakeholders at all levels
- Knowledge of engineering design standards, specifications, regulatory requirements, and capital project delivery processes
- Experience coordinating A/E firms and managing design deliverables and governance
What We Do
Pinnaql, Inc. is a professional services consulting firm providing quality, regulatory, and operational excellence solutions to biopharmaceutical, medical device, and CDMO companies worldwide. The company specializes in laboratory validation, engineering, and compliance, helping regulated life sciences organizations navigate manufacturing challenges, reduce execution risks, and accelerate the transition from lab innovation to commercial market readiness.
