Manufacturing Associate III

2 months ago

Woodinville, United States Inventprise Inc. Full time
Job DescriptionJob DescriptionSalary: $38.00 to $42.00 / hourly DOE

About Inventprise


At Inventprise, developing innovative and widely available vaccines is in our DNA. By producing targeted vaccines for populations worldwide, we're addressing global health inequalities and empowering people to live healthy lives—no matter where they live. Headquartered in Redmond, WA, our goal is to deliver affordable, effective vaccines at large-scale to Low and Middle Income Countries, as well as populations in the U.S. and around the world. Inventprise is committed to creating a diverse and inclusive workplace, where our people are inspired to do their best work. We’re proud to have some of the world’s most qualified industry scientists, researchers, and manufacturing professionals on our team, and strive to create a vibrant, dynamic presence in the Washington State Life Sciences environment.


What the Role Offers - Manufacturing Associate III


The Manufacturing Associate III is responsible for executing and monitoring manufacturing processes on the plant floor, is a subject matter expert on manufacturing operations, and provides training and guidance to junior operators


The Manufacturing Associate III is skilled in navigating cGMP and GDP practices and will execute administrative and compliance-related tasks including non-conformance investigation and report writing, generation and execution of CAPAs, and revision and creation of Batch Records and Standard Operating Procedures.


Shift Times


You may be required to work on shifts A, B, and C depending on business needs. Evening and weekend work may be required. As a non-exempt employee, you are entitled to a 30-minute meal break, which is unpaid. You are also entitled to a paid 10-minute rest period for every 4 hours worked.


Shift A: SUN MON TUE and alternate WED - 6:00 AM to 6:00 PM
Shift B: THUR, FRI, SAT and alternate WED - 6:00 AM to 6:00 PM
Shift C: MON to FRI - 3:00 PM to 11:00 PM (Second Shift)


What You Need to Succeed


  • Develop a culture of safety throughout the plant.
  • Execute recipes on the Manufacturing Plant automated control systems.
  • Perform major process operations including the following:
    • Fermentation, 
    • Chromatography
    • Tangential Flow Filtration
    • Conjugation
  • Monitor active processes.
  • Assist in the optimization of production processes.
  • Clean in Place (CIP) and Steam in Place (SIP) of process equipment
  • Order materials as needed for batch processing.
  • Media and Buffer Prep in accordance with SOPs and batch records.
  • Document all completed work on batch records following Good Documentation Practices.
  • Perform compliance-related tasks in the company Quality Management System including initiation and completion of non-conformances and CAPAs.
  • Perform root cause investigations of non-conformances.
  • Participate in Risk Assessments as required.
  • Participate as a Subject Matter Expert in internal and External audits.
  • Provide floor leadership to Junior staff.
  • Assist in organization and ensure completion of scheduled daily tasks.
  • Revise Standard Operating Procedures as needed.
  • Revise batch records as required.
  • Support a culture of continuous improvement throughout manufacturing.
  • Floor review of executed batch records and logbooks.
  • Organize Manufacturing support areas, maintaining proper organization and cleanliness.
  • Collect biohazard waste from the facility and place it in allotted Stericycle bins.
  • Support 2nd shift and weekend duties as required.
  • Adhere to applicable training requirements, as per Inventprise training policy (including formal GMP training).
  • Adhere to applicable safety requirements, as per Inventprise safety procedures.
  • Adhere to applicable employee conduct criteria, as per the Inventprise Human Resources Manual.
  • Capable of efficiently and effectively using computer-based technology to accomplish workflow.
  • Other duties as required.


Required Qualifications:


  • Bachelor’s degree or equivalent Experience.
  • 5+ years of cGMP-related manufacturing experience in the biopharmaceutical industry.
  • Experience with manufacturing process equipment.
  • Knowledge of biological and/or chemical handling.
  • Proficient in Microsoft Office applications.


Physical Demands:


  • Must be present on site for all related responsibilities and be able to routinely perform activities as defined above.
  • Must be able to stand for extended periods of time.
  • Must be able to dress in sterile gowning in the form of scrubs and clean room coveralls.
  • Ability to handle and work with potentially hazardous chemicals per standard operating procedure.
  • Must be able to lift up to 30 pounds.


Mental Demands:


  • Excellent oral and written communication skills.
  • Highly organized with an attention to detail
  • Must maintain a high level of alertness and acuity for analytical review and processing of documentation, daily.
  • Able to work independently with changing priorities.


Working Conditions:


  • Extended periods of time on the computer.
  • Extended periods of time on your feet.
  • Working in a warm environment wearing sterile gowning.
  • Working with chemicals per standard operating procedure.


Estimated Base Salary: $38.00 to $42.00 / hourly DOE


Benefits:


  • Medical, Dental, Vision, FSA, or HSA: Inventprise contributes 80% toward the Medical, Dental, and Vision coverage for the employee, and their enrolled spouse, and dependents. Medical plans are currently provided through Premera Blue Cross.
  • 401(k) program: Inventprise offers both pre-tax 401(k) and post-tax Roth retirement savings plans, letting you decide how you want to save for the future. We also make an employer contribution of 3% of your total earnings each pay period, regardless of whether you contribute.
  • Paid Time Off: Generous PTO, in addition to paid holidays.
  • Stock & Bonus Plans: Employees are eligible to participate in the Company’s Bonus and Stock plans.


Our People-First Philosophy


At Inventprise, you’ll be part of a world-class team working on innovative vaccines and technologies that have global impact. Our people are an integral part of our strategy, allowing us to grow as a company and improve our performance year-over-year.
Our company was built on the belief that by working together, we have the ability to make the world a better place and improve lives. We have a growth mindset and are constantly looking for ways to enhance our contributions to improve global health. We believe that when we support each other and set high standards, we are able to do our best work.


Equal Opportunity Employer


Inventprise is an equal-opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender, identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.

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