Provide vision and leadership to strategic projects with
significant site impact. Ensure new products are launched from the site in
alignment with contract goals. Manage the performance of projects or
significant subsystems associated with new products by influencing,
coordinating, and driving activities, initiatives, and development deliverables
across cross-functional teams. Direct all phases of new product development
projects from inception through completion from an Operations perspective. Lead
project review sessions focusing on cost, schedule, and technical performance.
Establish milestones, monitor adherence to plans and schedules, identify
issues, and implement solutions. Demonstrate strong leadership, clear
communication, and the ability to build effective cross-functional working
relationships. Ensure Value Improvement Projects (VIP) and new product
initiatives are completed in alignment with contract expectations.
· Project Planning & Definition: Define
project goals, scope, resource and cost estimates, timeline, and risks.
Facilitate cross-functional discussions to develop project proposals.
· People Leadership: Manage large, multi-project,
multi-site cross-functional teams; provide performance input; foster strong
alignment.
· Value Improvement (VIP): Oversee VIP
initiatives; identify, communicate, and manage risks.
· Project / Program Management: Lead initiation,
planning, execution, control, and close-out activities; ensure team ownership
of plans, schedules, and budgets.
· Process Management: Ensure activities follow
established processes; maintain documentation discipline; reinforce VIP and NPE
best practices.
· Communications & Reviews: Drive
cross-functional communication; serve as liaison between teams and leadership;
lead phase reviews; maintain documentation including minutes, issue logs, and
metrics.
· New Product Excellence (NPE): Implement NPE
methods; manage NPE risks and deliverables.
RequirementsExperience Requirements
· 5–7+ years of experience in manufacturing
engineering or quality engineering within an FDA-regulated industry (medical
devices, pharmaceuticals, biotechnology, diagnostics, or similar).
· Strong knowledge of FDA Quality System
Regulation (21 CFR Part 820), Good Manufacturing Practices (GMP), and ISO
13485.
· Experience supporting new product introductions
(NPI/NPD), including process development, equipment qualification, and process
validation.
· Hands-on experience with risk management (FMEA,
hazard analysis), root cause investigations, and CAPA systems.
· Proven collaboration with Operations, Quality
Assurance, Regulatory, R&D, and Supply Chain teams.
· Familiarity with controlled documentation
systems, engineering change processes, and manufacturing readiness
requirements.
· Experience ensuring compliance with quality
system procedures and regulatory expectations across the project lifecycle.
Skills Required
- 5-7+ years of experience in manufacturing engineering or quality engineering
- Strong knowledge of FDA Quality System Regulation (21 CFR Part 820)
- Experience supporting new product introductions
- Hands-on experience with risk management and CAPA systems
- Proven collaboration with Operations, Quality Assurance, Regulatory, R&D
What We Do
ISPV Inc. is a Life Science company that leads Productivity & Validation projects for the Pharmaceutical and Food industries.
