Manufacturing Technical Specialist
4 weeks ago
About the Role:
Innova Solutions is seeking a highly skilled Manufacturing Technical Specialist to join our team. As a key member of our Operations Process Support and Process Engineering team, you will play a critical role in the startup of our state-of-the-art large molecule drug substance facility.
Key Responsibilities:
* Collaborate with the existing staff in the stainless steel operations and Clinical Supply Center to support the entire process from initial cell bank thaw through bulk freeze.
* Work closely with the Automation engineering team to coordinate control systems design, installation, and commissioning needed for the core processing systems.
* Participate in safety assessments and reviews to ensure a safe working environment.
* Ensure necessary operating procedures are in place prior to CQ execution on the assigned unit operations.
* Develop and revise training materials and curriculum as needed.
* Perform and update risk assessments in partnership with network and Quality counterparts.
Requirements:
* 15 or more years of work experience in the pharmaceutical or related industry.
* 10 or more years of direct or indirect people and team management experience.
* 5 or more years of work experience in a cGMP regulated environment, preferably in biologics manufacturing.
* Excellent verbal and written communication skills.
* Ability to influence at all levels of an organization.
* Comfortable working in an agile and ambiguous environment.
Work Environment:
* Work in office, manufacturing, and to a lesser extent, laboratory environments.
* May be on feet for 4 to 5 hours a day.
* Able to work a flexible schedule to meet start-up activity requirements.
* Lifting up to 25lbs may be required.
* May work in the clean room environment that requires gowning in the form of hospital scrubs, coveralls, gloves, and steel toe boots.
* May work with hazardous materials and chemicals.
Benefits:
Innova Solutions offers benefits (based on eligibility) that include medical and pharmacy coverage, dental and vision insurance, 401(k), health saving account (HSA), and flexible spending account (FSA), life insurance, pet insurance, short-term and long-term disability, accident and critical illness coverage, pre-paid legal and ID theft protection, sick time, and other types of paid leaves (as required by law).
Pay Range:
$76-$81 per hour.
Note: Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.
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