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Manager Aseptic Processing Jobs in California (NOW HIRING)

Hims and Hers Health, Inc.

Quality Specialist

Los Alamitos, CA · On-site

$70K - $85K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Working under the direction of QA management, the Quality Specialist supports release and ... Aseptic processing experience and familiarity with ISO 14644, contamination control, and sterility ...

Artiva Biotherapeutics, Inc.

Senior Manager, MSAT

San Diego, CA

$165K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

The Sr. Manager, MSAT Engineer is accountable for driving results in a fast-paced environment by ... Cell culture, celltherapyor aseptic processing experience * Equipment and/ornew technologydesign ...

AMRESCO

Process Engineer III

Bakersfield, CA · On-site

Provides operational leadership by managing the Process Design & Detail Engineering including ... and aseptic processing systems is a plus. * Must possess excellent communication and problem ...

Avantor Inc.

Process Engineer III

Bakersfield, CA · On-site

Provides operational leadership by managing the Process Design & Detail Engineering including ... and aseptic processing systems is a plus. * Must possess excellent communication and problem ...

Artiva Biotherapeutics

Senior Manager, MSAT

San Diego, CA · On-site

$165K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

The Sr. Manager, MSAT Engineer is accountable for driving results in a fast-paced environment by ... Cell culture, cell therapy or aseptic processing experience * Equipment and/or new technology ...

Artiva Biotherapeutics, Inc.

Senior Manager, MSAT

San Diego, CA · On-site

$150K - $165K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

The Sr. Manager, MSAT Engineer is accountable for driving results in a fast-paced environment by ... Cell culture, cell therapy or aseptic processing experience * Equipment and/or new technology ...

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Manager Aseptic Processing information

What is a manager aseptic processing?

A Manager of Aseptic Processing oversees the sterile production environments in pharmaceutical or biotechnology manufacturing. They are responsible for ensuring that products are processed and packaged without contamination, following strict regulatory and safety standards. Their role includes supervising staff, maintaining compliance with Good Manufacturing Practices (GMP), conducting risk assessments, and implementing process improvements. They also play a key part in training employees and managing documentation to ensure product quality and patient safety.

What are the key skills and qualifications needed to thrive as a manager aseptic processing?

To thrive as a Manager Aseptic Processing, you need a strong background in microbiology, pharmaceutical manufacturing, quality assurance, and regulatory compliance, often supported by a relevant degree and experience in sterile production environments. Familiarity with Good Manufacturing Practices (GMP), cleanroom management systems, and environmental monitoring tools is essential. Leadership, attention to detail, and effective communication are crucial soft skills for managing teams and ensuring strict adherence to protocols. These skills and qualities are vital to maintain product sterility, meet regulatory standards, and ensure patient safety in pharmaceutical operations.

What are some common challenges faced by a manager aseptic processing, and how can they be addressed?

Managers in Aseptic Processing often face challenges related to ensuring strict compliance with regulatory standards, maintaining a contamination-free environment, and leading cross-functional teams in high-pressure situations. Addressing these challenges requires staying updated on evolving industry guidelines, fostering a culture of continuous training, and implementing robust monitoring systems. Effective communication and collaboration with Quality Assurance, Maintenance, and Production teams are also crucial for swiftly resolving issues and upholding product safety.

What is the difference between Manager Aseptic Processing vs Aseptic Processing Technician?

AspectManager Aseptic ProcessingAseptic Processing Technician
CredentialsBachelor's degree in life sciences or related field, GMP training, leadership experienceHigh school diploma or associate degree, GMP training
Work EnvironmentSupervisory role overseeing aseptic processes in pharmaceutical manufacturingHands-on role operating aseptic equipment in cleanroom settings
ResponsibilitiesManaging teams, ensuring compliance, process optimizationPerforming aseptic procedures, equipment setup, documentation

The Manager Aseptic Processing oversees the aseptic manufacturing process, focusing on team management and compliance, while the Aseptic Processing Technician handles the direct operation of aseptic equipment. Both roles require GMP training and work in sterile environments, but the manager has additional leadership and oversight responsibilities.

What are the most commonly searched types of Aseptic Processing jobs in California?

The most popular types of Aseptic Processing jobs in California are:

What are popular job titles related to Manager Aseptic Processing jobs in California?

For Manager Aseptic Processing jobs in California, the most frequently searched job titles are:

What job categories do people searching Manager Aseptic Processing jobs in California look for?

The top searched job categories for Manager Aseptic Processing jobs in California are:

What cities in California are hiring for Manager Aseptic Processing jobs?

Cities in California with the most Manager Aseptic Processing job openings:

Manager Aseptic Processing jobs near you

Sr. Manager, Manufacturing Engineering

Orthofix Holdings, Inc.

Irvine, CA • On-site

$165 - $190/hr

Other

Posted 12 days ago

Job description

Senior Manager – Manufacturing EngineeringResponsibilities
  • Lead new process development activities for R&D and complex manufacturing projects.
  • Facilitate team development, budget control, planning, and continuous improvement activities.
  • Apply Design Control and Risk Management procedures to establish project plans and product requirements.
  • Collaborate with interdepartmental personnel and external partners to uphold project plans and achieve objectives.
  • Provide timely project updates to leadership on a recurring basis.
  • Generate and analyze test data and reports to verify that designs meet functional and performance specifications.
  • Interface with vendors regarding technical issues while supervising designs throughout the manufacturing process.
  • Provide training, mentorship, and supervision to junior engineering and product development staff.
  • Develop intellectual property based on newly developed products.
  • Lead departmental meetings as scheduled and perform other duties as assigned.
Required Qualifications
  • Bachelor’s Degree in Engineering (minimum).
  • 10+ years of experience in medical device manufacturing.
  • At least 2 years of leadership experience, including hiring and coaching.
  • Ability to generate and maintain a budget.
  • Expertise in FDA QSR and ISO 13485 principles, including Design Controls and Risk Management.
Preferred Qualifications
  • Master’s Degree in Engineering (Biomedical or Mechanical preferred).
  • Spine/Orthopedic device experience.
  • CAD experience (Pro‑Engineer/Creo, SolidWorks, or equivalent).
  • Human tissue processing and lyophilization experience.
  • Familiarity with aseptic processing.
Physical Requirements / Working Conditions

Frequent exposure to chemicals and/or solvents; reasonable accommodations may be made to allow qualified individuals with a disability to perform the essential functions of this position.

Salary: $165,000 to $190,000 per year (California), plus bonus and benefits.

Equal Employment Opportunity Statement

We are committed to providing equal employment opportunities to all employees and applicants without regard to race, ethnicity, religion, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, marital status, pregnancy, age (40 and over), protected medical condition, genetic information, disability, reproductive health decision-making, medical leave or other types of protected leave, domestic violence victim status, political affiliation, or any other protected status in accordance with all applicable federal, state, and local laws. This policy extends to all aspects of our employment practices, including recruiting, hiring, discipline, termination, promotions, transfers, compensation, benefits, training, leaves of absence, and other terms and conditions of employment.

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