Acting as a SME (Subject Matter Expert). Work hand in hand with other manufacturing and production teams, educating them on continuous manufacturing/production activities. Single handedly, enabling Vertex to do Continuous Manufacturing (which they do not have otherwise)

* Take leading role in manufacturing buffers and solutions for the production facility.

* Responsible for coordinating production support activities for multiple projects (Parts wash, autoclave, integrity tests, material/supply requests, GMP room cleaning)

* Accountable for all personnel, material and product flow throughout the Buffer preparation and Production Support areas.

* Work closely with production management to develop departmental initiatives and strategies to increase efficiencies.

* Coordinate with the Facilities Department to ensure all equipment and rooms are maintained according to established standards and schedules.

* Insures health and safety adherence and compliance.

* Identify equipment issues and take action to resolve.

* Create and update all SOPs.

* Assist in investigations concerning manufacturing issues.

* Assist in the IQ/OQ/PQ of production equipment.

* Maintain active role in all buffer manufacturing activities.

* Responsible for interns.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .

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Required Skills & Experience

5+ years of Buffer/Cleaning Experience

SOP documenttion

cGMP experience

Pay Rate: $45/hr-$50/hr

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.