What are the responsibilities and job description for the Turnover Package (TOP) Coordinator position at Radiance Technologies LLC?
Turnover Package (TOP) Coordinator
Location: Wilson, NC
Job Type: 100% Onsite
Employment Type: Contract (18 Months) with Strong Possibility of Extension
Industry: Pharmaceutical Manufacturing
Position Summary
We are seeking an experienced Turnover Package (TOP) Coordinator to support a major pharmaceutical capital project in Wilson, NC. This is a 100% onsite opportunity where you will serve as the primary liaison between Construction, Engineering, Equipment Vendors, Commissioning & Qualification (CQV), Validation, and Quality teams to ensure turnover documentation packages are complete, technically accurate, and compliant before systems are released for commissioning and qualification activities.
The ideal candidate will have experience supporting GMP-regulated pharmaceutical, biotechnology, or medical device manufacturing environments with strong knowledge of turnover documentation, commissioning, qualification, validation, and documentation control processes.
This is an 18-month contract with a strong possibility of extension based on project requirements and performance.
Key Responsibilities
- Review turnover packages submitted by contractors, equipment vendors, subcontractors, and engineering teams for completeness, accuracy, and compliance.
- Verify documentation aligns with approved system boundaries, turnover strategies, and validation requirements.
- Ensure turnover documentation supports commissioning, startup, qualification, and validation readiness.
- Review and verify required documentation including:
- Redlined drawings
- Inspection and test records
- Material certificates
- Calibration records
- Weld documentation
- FAT/SAT documentation
- Vendor manuals
- Turnover deliverables
- Ensure compliance with GMP, GDP, documentation control requirements, and internal quality standards.
- Maintain organized electronic turnover documentation within project document management systems.
- Coordinate documentation requirements between Construction, Engineering, CQV, Validation, Quality, and Equipment Vendors.
- Facilitate resolution of documentation deficiencies, punch list items, and turnover gaps before package acceptance.
- Participate in system walkdowns to verify installations comply with approved engineering documentation.
- Support punch list development, tracking, and project closeout activities.
- Maintain turnover trackers, documentation metrics, and project status reports.
- Assist with turnover package approvals, document routing, and final project closeout documentation.
- Support continuous improvement initiatives for turnover documentation and project execution.
Minimum Qualifications
- Experience supporting GMP-regulated Pharmaceutical, Biotechnology, or Medical Device manufacturing projects.
- Strong understanding of Commissioning, Qualification, Validation (CQV), and turnover documentation processes.
- Experience reviewing engineering, construction, vendor, and turnover documentation packages.
- Ability to interpret:
- P&IDs
- Engineering drawings
- Isometrics
- Technical specifications
- Working knowledge of GMP, GDP, and documentation management practices.
- Experience participating in system walkdowns and punch list management.
- Strong organizational, communication, and coordination skills.
- Ability to manage multiple priorities in a fast-paced project environment.
- Proficiency with Microsoft Office and electronic document management systems.
Preferred Qualifications
- Experience supporting pharmaceutical facility expansions or large capital projects.
- Familiarity with electronic turnover management platforms.
- Experience supporting CQV lifecycle execution.
- Knowledge of ASTM, ISPE, commissioning, and qualification best practices.
- Previous EPCM or construction project experience is highly desirable.
Why Join This Opportunity?
- Work on a high-profile pharmaceutical manufacturing project.
- Collaborate with multidisciplinary engineering, construction, CQV, and quality teams.
- 100% onsite role in Wilson, NC.
- 18-month contract with a strong likelihood of extension.
- Opportunity to contribute to complex GMP commissioning and validation activities while supporting critical project milestones.
Interested candidates can forward their updated resume to Spatel@pharmarg.com
Pay: $110,890.00 - $115,786.00 per year
Work Location: In person
Salary : $110,890 - $115,786