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Manufacturing Associate II

4 months ago

Woodinville, United States Inventprise Inc. Full time
Job DescriptionJob DescriptionSalary: $32.00 to $37.00 / hourly DOE

Title: Manufacturing Associate II


Overtime Status: Non-Exempt


Employment Status: Full-Time


Pay Range: $32.00 to $37.00 / hourly DOE


The hiring pay range for this position is $32.00 to $37.00 per hour based on skills, education, and experience relevant to this role.


Inventprise is a mission-driven bio-pharmaceutical company addressing global health inequalities by empowering people to live healthy lives. We do this by developing novel vaccines targeting infectious diseases for which there are no current preventive interventions or by optimizing currently marketed vaccines to provide a broader spectrum of protection, making them cheaper and more stable than before. We aspire to provide breakthrough public health interventions for all populations, globally. Inventprise is led by pioneers in vaccine discovery, seasoned experts in manufacturing and vaccine development, and proven commercialization veterans.  


At Inventprise, we believe our people are our most valuable asset. We are strongly committed to a range of workplace programs that support the well-being, growth, and engagement of our employees and our business. What we offer:


Benefits:

Effective the first of the month following the date of hire, employees are eligible to participate in the following Inventprise employee benefit programs:


  • Medical, Dental, Vision, FSA, or HSA:  Currently Inventprise contributes 80% toward the Medical, Dental, and Vision coverage for the employee, and enrolled spouse and dependents.  Medical plans are currently provided through Premera Blue Cross.
  • 401(k) program: Inventprise contributes 3% of employee base pay each pay period to their 401(k) account. Employee contributions are at the discretion of the employee.
  • Paid Time Off: Employees start PTO accruals at the rate of 5.83 hours each pay period - annualized equivalent of 140 hours/year.
  • Paid Holidays: Inventprise offers 9 paid holidays each year: New Year's Day, Memorial Day, Independence Day, Labor Day, Thanksgiving Day, Day after Thanksgiving Day, Christmas Day, and two floating holidays.
  • Stock & Bonus Plans: Employees are eligible to participate in the Company’s Bonus and Stock Award Plans.


Job Summary


The Manufacturing Associate II is responsible for executing and monitoring manufacturing processes on the plant floor, is a subject matter expert on one or more primary manufacturing operations (Fermentation, Chromatography, Tangential Flow Filtration, Conjugation)) and provides training and guidance to junior operators on those operations.


The Manufacturing Associate II is familiar with navigating cGMP quality systems and will assist in executing 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)


Job Responsibilities:


Essential Functions:


  • 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 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.
  • Assist with compliance related tasks in the company Quality Management System including initiation and completion of non-conformances and CAPAs.
  • Assist with performing root cause investigations of non-conformances.
  • Participate in Risk Assessments as required.
  • Participate as 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 facility and place in allotted Stericycle bins.
  • Support 2nd shift and weekend duties as required.
  • Other duties as required.


Non-Essential (Additional) Functions:


  • 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 Inventprise Human Resources Manual.
  • Capable of efficiently and effectively using computer-based technology to accomplish workflow.


Job Specifications:


Required Education, Experience and Skills:


  • Bachelor’s degree or equivalent Experience
  • 3+ 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:


  • Ability to sit and use a computer for extended periods.
  • Ability to thrive in a fast-paced and dynamic environment with ambiguity.
  • Strong problem-solving and decision-making skills.
  • Ability to manage multiple priorities and meet deadlines.


Mental Demands:


  • Excellent oral and written communication skills.
  • Highly organized with an attention to detail
  • Must maintain high level 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 warm environment wearing sterile gowning.
  • Working with chemicals per standard operating procedure.


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.