Manufacturing Technician
Synectics Inc. · Frederick, MD · 2 mo ago
ManufacturingContract
About the role
The Product Specific 2026 Campaign Support role provides operational support for C-Pak Freeze activities activities and work in controlled cold room environments in support of the 2026 campaigns. The individual will execute approved manufacturing and material handling activities in compliance with site procedures, training requirements, safety expectations, and electronic systems used to support operations.
Responsibilities
- Support campaign readiness and execution following completion of required training and access provisioning.
- Perform C-Pak Freeze operations in accordance with approved procedures, work instructions, and on-the-job training requirements.
- Work in temperature-controlled cold room environments, including 2-8°C and -40°C areas, in accordance with site safety and operational procedures.
- Execute activities within PAS-X as an EBR Operator, ensuring accurate electronic batch record interaction and compliance with system requirements.
- Follow site documentation requirements, including completion of required read-and-sign training and adherence to applicable work instructions.
- Support audit-ready operations by maintaining compliance with procedural, documentation, and system use expectations.
- Work collaboratively with qualified trainers and site personnel, including OJT support delivered by designated trainers as applicable.
- Maintain required access and operator qualifications for campaign-related systems and operational areas.
Training & Onboarding Timeline
- Week 1: Focus on SOP and training, with breaks for shadowing and observations. Gain an understanding of workflows, documentation, and daily routines.
- Week 2: Continued SOP and hands-on training. Begin performing role-specific duties with oversight, such as handling selected tasks/projects, navigating systems, and interacting with stakeholders. Constructive feedback is continuous, supported by SOPs and checklists.
- Week 3: Independent application and problem-solving. Perform routine tasks with lead. Regular check-ins, debriefings, and encouragement to ask questions build confidence and competence. Focus on simulating real scenarios the trainee might face once fully transitioned.
- Week 4 (or Final Half-Week): Assessment and transition. Complete a readiness assessment through a review of outcomes, feedback from mentors, and possibly a knowledge check or demonstration. Final documentation and a wrap-up session clarify lingering questions. A plan for ongoing mentorship and check-ins after shift assignment is outlined.
Qualifications
- HS diploma or GED.
- 1-2 years experience in a GMP environment.
Training Requirements
The estimated training effort is ~100 hours total, with 3.5-4 weeks considered a realistic timeline for a proficient individual supporting C-Pak Freeze.
- FMC Pas-X: EBR Operator (~5hrs)
- FMC PAS-X 4: Introduction to PAS-X for EBR Operators - WBT - 30mins
- FMC PAS-X 5: EBR Access Approval - OJT - 45mins
- FMC Pas-x: Core Training
- 6 read and signs
- FMC PAS-X 12: What is PAS-X - WBT
- WI-0013562 How to Perform a Pas-X system Audit Review
- FMC PCN: 630 Freeze/Thaw Operator (~2 hrs)
- 4 read and signs
- FMC SCO SFT: Freeze/Thaw Activities (~10hrs)
- 19 read and signs
- FMC SCO SFT: C-Pak Freeze/Thaw (~38hrs)
- OJT - (~36hrs)
- 5 read and signs (~2.5hrs)
- FMC Access: Campus SCO Restricted Clearance Access - Freeze/Thaw (~1.5 hr)
- 3 read and signs
- FMC SCO SFT: Shipping & Freeze Thaw Basics (~2hrs)
- 4 read and signs
Benefits
- Healthcare Insurance: Eligible employees and their dependents receive healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full-time employment with Synectics. Premiums are subsidized.
- Dental Insurance: Eligible employees and their dependents receive a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full-time employment with Synectics.
- Vision Insurance: Eligible employees receive vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full-time employment with Synectics.
- 401(k) Plan: Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first of the month following at least 1 calendar year after employment begins.