Aseptic Process Engineer at CAI

Italy

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, BiotechnologyIndustries

Requirements

Degree in microbiology, biology, biotechnology, or a science-related field
Experience in Sterility Assurance assessment within a regulated manufacturing industry
Experience in Environmental qualification and Contamination control Strategy
Experience in aseptic process simulation risk assessment, validation strategy and oversight
Experience in Contamination control strategy of pharmaceutical sterile products
Experience in executing sterilizing equipment qualification
Experience with microbiological and biological method application and validation
Understanding of Good Documentation Practices (GDP) and general quality laboratory function
Strong attention to detail, organizational skills, and drive to be successful
Experience with aseptic technique and biological safety cabinets
Proficient in spoken and written English and/or a native language

Responsibilities

Support Sterility Assurance assessments
Participate in cross-functional projects, including customer meetings
Participate in the writing of protocols, reports, and specifications
Drive deliverables to completion with structured timelines
Execute sterilizing equipment qualification
Validate microbiological and biological methods
Contribute to contamination control strategy development

Skills

Key technologies and capabilities for this role

Sterility AssuranceEnvironmental QualificationContamination ControlAseptic Process SimulationValidation OversightEquipment QualificationMicrobiological Method ValidationAseptic TechniqueBiological Safety CabinetsGDP

Questions & Answers

Common questions about this position

What is the salary for the 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?

Required skills include understanding of Good Documentation Practices (GDP), strong attention to detail and organizational skills, experience with aseptic technique and biological safety cabinets, and proficiency in spoken and written English.

What experience is needed for this Aseptic Process Engineer position?

Candidates need experience in Sterility Assurance assessment, environmental qualification and contamination control strategy, aseptic process simulation risk assessment and validation, contamination control of pharmaceutical sterile products, sterilizing equipment qualification, and microbiological method validation.

What education is required for the Aseptic Process Engineer job?

A degree in microbiology, biology, biotechnology, or a science-related field is required.

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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