What are the responsibilities and job description for the Project Manager, CQV Packaging position at Synterex?
Synterex, Inc. is a consortium of highly experienced clinical development professionals specializing in medical writing, submission publishing, and clinical science and operations support. Synterex offers remote or on-site services, with a focus on providing clear, concise, accurate, and fully compliant documentation, from early drug development through post-approval. Synterex also supports the operations of life sciences facilities, which may include processes across regulatory, compliance, CQV, and quality solutions.
Synterex is seeking a Project Manager (PM) to manage a validation engineer contractor team and day-to-day activities associated with the respective project, budget and schedule. The PM will also generate deliverables and assist with execution activities as needed. A traveling resource may be considered with a per diem included.
Job Title : CQV Packaging Project Manager
Duration : February 2025 - August 2025 (with possible extension)
Hours : 40 hours / week
Location : Hybrid, with on-site support needed during test execution; Hazel Crest, IL (Homewood, IL)
Project Scope : ~4,400 sq ft. New Packaging Facility
- 3 x Key Pack Packaging Lines and associated equipment - equipment estimated to arrive in January
- 1 x Bottling Line and associated equipment - equipment estimated to arrive in March or April
- 2 x Blister Pack (thermoforming) Packaging Lines with package cartoner and associated equipment - equipment estimated to arrive in March or April
- 1 x Ambient Warehouse with separate areas for receipt and shipping : temperature, humidity and pressure monitored
- Storage areas
- Quarantine area
- Critical Utilities : electricity and dripless clean air system
- Building Alarm System (BAS) to monitor for environmental out of specification values (temperature, relative humidity(RH), pressure)
- 5 x Chart monitoring systems (1 quarantine area, 3 packaging suites, 1 storage area)
- 1 x Dust collecting system for Key Pack Lines
Essential Duties & Responsibilities
Supporting all aspects of CQV, which may include some SOP revision, deliverable generation, and test execution
Requirements
For further information or to apply, please reach out to careers@synterex.com.
Synterex provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
