Strategic Operations Project Specialist
About The Position
As a Strategic Operations Project Specialist, you will serve as a technical and project management resource supporting manufacturing readiness, process improvements, quality initiatives, and cross-functional operational projects. You will partner with Manufacturing, Quality, Engineering, Validation, MSAT, and Project Management teams to drive successful project execution and operational excellence. This role requires strong technical knowledge, project ownership, stakeholder management, and the ability to lead initiatives from planning through implementation in a cGMP manufacturing environment.
Requirements
- High school diploma or equivalent required
- 5+ years of experience in biotechnology, pharmaceutical manufacturing, process operations, engineering, quality, or a related industry
- Experience leading or supporting projects in a regulated manufacturing environment
- Knowledge of cGMP requirements and quality systems
- Experience with change controls, CAPAs, investigations, risk assessments, or validation activities
- Strong project management, planning, and organizational skills
- Strong analytical and problem-solving abilities with a continuous improvement mindset
- Excellent written and verbal communication skills
- Ability to build relationships and work effectively across multiple departments and stakeholder groups
Nice To Haves
- Bachelor's degree in Engineering, Biotechnology, Life Sciences, Manufacturing, or a related field preferred
Responsibilities
- Lead cross-functional projects that support manufacturing readiness, process improvements, and operational excellence
- Manage project scope, timelines, deliverables, risks, and stakeholder communications from initiation through completion
- Provide technical support and subject matter expertise for manufacturing processes, equipment, and systems
- Support technical transfers, campaign readiness activities, and departmental readiness initiatives
- Lead change control activities and complete project-related tasks to support successful implementation
- Develop, track, and report key performance indicators to measure project and operational success
- Investigate operational issues and identify opportunities for continuous improvement
- Support procurement, installation, and implementation of manufacturing equipment and systems
- Collaborate with Manufacturing, Quality, Engineering, Validation, and MSAT teams to achieve business objectives
- Support customer-facing activities and represent Strategic Operations on Joint Project Teams when required
- Support team activities, meetings, and continuous improvement efforts
Benefits
- An agile career and dynamic working culture
- An inclusive and ethical workplace
- Compensation programs that recognize performance
- Medical, dental, and vision insurance
- Opportunities to grow and develop your career
- A collaborative and team-focused environment
- The opportunity to support the delivery of life-changing therapies
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
