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You will partner closely with the Engineering & Validation leadership team and will be responsible for upstream/downstream process & utility validation of GMP manufacturing systems at the new state of the art Gene Therapy Manufacturing facility in Bedford, Massachusetts.

You will work alongside senior team members and be focused on the planning for the Manufacturing Facility Validation. This will give students a unique perspective on what it is like to support a gene therapy manufacturing site. This will not be a traditional on the floor hands on experience. The person who fills this role will be a part of a team that supports planning, execution, and decision- making for ongoing validation activities.

Work Model: 

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site and thus will be subject to certain on-site safety protocols during the pandemic.

Responsibilities:

• Attend Validation planning meetings
• Collaborate with different workstreams
• Execute testing on Manufacturing and Utilities Equipment
• Documentation development
• Generate and maintain project trackers and spreadsheets
• Routinely execute simple and complex processes following established
• Demonstrate general knowledge of standard manufacturing practices and
• Strict adherence to current good manufacturing practices, standard operating procedures, and manufacturing
• Follow written procedures for clear and accurate documentation of equipment operation and process instructions.
• Monitor process operations to ensure compliance with
• Assist in the investigation of procedural
• Practice safe work habits and adhere to safety procedures and guidelines.
• Utilize knowledge to improve operational efficiency.
• Other duties as assigned

Requirements:

• Pursuing a Bachelor’s degree in a relevant field of study (e.g., Engineering, Science), with minimum of 2 years completed
• Enrolled as a full-time student with plans to return to school in fall term
• Available to work 40 hours/week during normal business hours
• Knowledgeable of Microsoft Office Suite (Word, Excel, PowerPoint)
• Flexible; adapts work style to meet organization needs
• Meticulous attention to detail
• Strong ability to follow through with tasks
• Ability to exercise sound judgment, reasoning, and problem solving
• Capable of completing assigned responsibilities and keeping manager informed of work status
• GMP experience is a plus
• Ambitious and self-starting attitude to take on responsibilities and own process improvements
• Ability to collaborate fluidly with peers, supervisors and cross functional support groups required
• Exceptional written, oral communication, and organizational skills required independently and with strategic collaborators

Physical Demands/Work Environment/Safety Considerations:

• Stand for extended periods of time wih periodic stooping / bending / kneeling.
• Ability to climb ladders and stairs of various heights.
• Able to lift, push, pull up to 50lbs.
• Work in a controlled environment requiring GxP gowning and wear protective clothing over the head, face, hands, feet, and body. This requires the ability to change clothes into appropriate gowning and personal protective equipment.
• Certain tasks may require use of a respirator; medical clearance will be required in advance.
• Must remove all make-up, jewelry, and contract lenses while in the manufacturing environment.
• Working in termperature-controled environments (cold rooms). #LI-ONSITE