Aseptic process engineer at CAI

Italy

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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

Key technologies and capabilities for this role

Aseptic TechniqueBiological Safety CabinetsEnvironmental QualificationContamination Control StrategyAseptic SimulationRisk AssessmentValidation StrategySterilization ProcessesMicrobiological MethodsBiological MethodsGDPLaboratory Quality

Questions & Answers

Common questions about this position

What is the salary for this Aseptic Process Engineer position?

This information is not specified in the job description.

Is this Aseptic Process Engineer role remote or onsite?

This information is not specified in the job description.

What skills are required for the Aseptic Process Engineer role?

Key skills include ability to work independently, strong attention to detail, excellent organizational skills, determination to achieve goals, and experience with aseptic technique and biological safety cabinets.

What education is needed for this position?

A Bachelor's degree in Microbiology, Biology, Biotechnology, or a related scientific field is required.

What makes a strong candidate for this Aseptic Process Engineer job?

Candidates with experience in environmental qualification, contamination control strategy, aseptic simulation risk assessment, sterile pharmaceutical products, sterilization processes, and microbiological methods, along with advanced English proficiency, will stand out.

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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