Manufacturing Support Associate 2
5 days ago
The Manufacturing Support Associate 2 plays a critical role in ensuring the smooth operation of our Drug Product Manufacturing facility. This position is responsible for providing reliable support to the manufacturing team, including the creation of standard operating procedures, process development, and documentation management.
Key Responsibilities- Support operational readiness initiatives, including site commissioning and qualification
- Own and drive drug product operational readiness document plan, contributing to the preparation of standard operating processes (SOPs) and documentation packages
- Participate in operational readiness project meetings and support factory acceptance testing (FAT) and site acceptance testing (SAT), as required
- Establish batch handling processes for Drug Product manufacturing
- Execute and drive minor projects, including change management requests and optimization projects
- Lead and guide shop floor deviation investigation from initiation through closure
- Provide training and mentor junior level team members
To be successful in this role, you will need:
- High School Diploma or GED with 6 years direct experience, or Associate's degree with 4 years of direct experience, or Bachelor's degree with 2 years of direct experience, or equivalent military training or experience
- Strong verbal and written communication skills
- Knowledge from operational experience with formulation, filling, and visual inspection processes and production equipment
- Knowledge of cGMP from a pharmaceutical production environment
- Ability to adapt in a fast-paced environment, pivot, and adjust plans accordingly
- Ability to think critically and have superior problem-solving skills
- Experience with IT systems (Office and ERP systems)
Associate degree in life sciences, BA/BS in life sciences or engineering, prior cGMP experience from a pharmaceutical production environment, and preferable operational experience with formulation, filling, and visual inspection processes and production equipment.
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