Manufacturing Technician

Description

• 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.
• Week 1: Orientation and Introduction In the first week, the trainee should be introduced to core team members, role expectations, and essential systems (access).
• Starting with SOP and training, with breaks for shadowing and observations.
• The week should focus on gaining an understanding of workflows, documentation, and daily routines.
• Week 2: Continued SOP and Hands on Training The second week moves to supervised hands-on tasks.
• The trainee begins to perform role-specific duties with oversight, such as handling selected tasks/projects, navigating systems, and interacting with stakeholders.
• Constructive feedback will be continuous, supported by SOPs and checklists.
• Week 3: Independent Application and Problem-Solving By the third week, the trainee should be performing routine tasks with lead.
• Regular check-ins, debriefings, and encouragement to ask questions further build confidence and competence.
• Focus should be on simulating real scenarios the trainee might face once fully transitioned, allowing for practical problem-solving and time management exercises.
• Week 4 (or Final Half-Week): Assessment and Transition In the final few days, the trainee completes 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.
• To ensure continued support, outline a plan for ongoing mentorship and check-ins after shift assignment

Qualification

• 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.

• Expected Training needed Training needed - ~(100 hrs) - 3.5-4 wks is realistic for proficient C-pack FMC Pas-X: EBR Operator (~5hrs)

• FMC Pas-x: EBR Operator

• 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)

• FMC SCO SFT: C-Pak Freeze

• 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 (add but I believe it will complete by equivalent) (~2hrs)

• 4 read and signs

• ACCESS needed

• Pas-X

• SAP

• PCN - B630 Freeze/Thaw Operator

• Cross-Training Plan Outline F/T (3.5-4 Weeks)

Benefits Healthcare Insurance: Synectics offers eligible employees and their dependents 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 by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents 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: Synectics offers eligible employees 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: The Synectics Inc. Investment Savings Retirement 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.

Synectics is an equal opportunity employer.