Aseptic process engineer at CAI

Italy

CAI Logo
Not SpecifiedCompensation
Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, BiotechnologyIndustries

Requirements

  • Bachelor's degree in Microbiology, Biology, Biotechnology, or a related scientific field
  • Understanding of Good Documentation Practices (GDP) and Laboratory Quality
  • Ability to work independently
  • Strong attention to detail
  • Excellent organizational skills
  • Determination to achieve goals successfully
  • Experience with aseptic technique and biological safety cabinets
  • Advanced proficiency in English (spoken and written) or native language proficiency
  • Experience in environmental qualification and contamination control strategy
  • Experience in process aseptic simulation risk assessment, validation strategy, and supervision
  • Experience in the contamination control strategy of sterile pharmaceutical products
  • Knowledge of equipment qualification elements for sterilization processes
  • Experience with applying and validating microbiological and biological methods

Responsibilities

  • Supporting sterility assurance evaluation in the regulated manufacturing industry
  • Participation in cross-functional projects, including meeting participation and direct client interaction
  • Drafting of protocols, reports, and specifications
  • Management of assigned tasks using structured work programs and timelines
  • Travel may be required (national and international)

Skills

Aseptic Technique
Biological Safety Cabinets
Environmental Qualification
Contamination Control Strategy
Aseptic Simulation
Risk Assessment
Validation Strategy
Sterilization Processes
Microbiological Methods
Biological Methods
GDP
Laboratory Quality

CAI

Consulting for operational readiness in healthcare

About CAI

CAI Technical Consulting Malaysia SDN, under the brand cagents.com, offers consulting services focused on operational readiness for clients in the pharmaceutical, biotechnology, and healthcare sectors. They conduct operational readiness assessments to evaluate a company's preparedness and tailor their services accordingly, which include project planning and asset management. CAI stands out from competitors by emphasizing professional development and industry collaboration, ensuring their team stays updated on industry trends. Their goal is to help clients achieve operational excellence and readiness for full-scale production.

Overland Park, KansasHeadquarters
1996Year Founded
$3.4MTotal Funding
PRE_SEEDCompany Stage
Industrial & Manufacturing, Biotechnology, HealthcareIndustries
1-10Employees

Benefits

100% Employee Owned
24 Days PTO/5 Sick days per year + Additional Holidays depending on Country
Medical / Dental / Vision (In accordance with each countries’ applicable regulations)
Professional Development (Approximately $5,000 paid career-related, continuing education)
ESOP/401k – 15% Company Contribution
Company Paid Long-Term Disability
Company Paid Life Insurance
Company Paid Parental Leave (In accordance with each countries’ applicable regulations)
Other Benefits Depending on Country

Risks

Competition from specialized firms in digital transformation may erode CAI's market share.
In-house consulting teams in corporations could reduce demand for CAI's services.
Remote work models decrease demand for traditional on-site consulting, impacting CAI's operations.

Differentiation

CAI offers comprehensive consulting services across multiple industries, including life sciences.
Their expertise in energy management aligns with the sustainability focus of data centers.
CAI's risk management services cater to the growing cybersecurity needs in process manufacturing.

Upsides

Demand for digital transformation in life sciences boosts CAI's automation consulting services.
Personalized medicine trends create opportunities for flexible manufacturing process consulting.
Data centers' focus on energy efficiency aligns with CAI's energy management expertise.

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