Senior CQV Engineer at CAI

Switzerland

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, Biotechnology, PharmaceuticalIndustries

Requirements

BS or MS in engineering, life sciences, or a related field
5+ years of CQV experience in life sciences, with strong expertise in DI/CSV/security
Familiarity with biotech, aseptic fill/finish, OSD, or gene therapy processes
Strong problem-solving, communication, and customer-focused skills
Flexibility to travel domestically and internationally as required
Hands-on experience with isolators, autoclaves, or part washers (nice to have)

Responsibilities

Lead and execute commissioning, qualification, and validation (C&Q) activities with a focus on safety and quality
Write, review, and revise qualification and verification documents, including IQ/OQ/PQ protocols, SOPs, master plans, and guidelines
Review and qualify lab equipment
Coordinate with contractors and vendors to complete testing and track C&Q progress against schedules
Support FATs, design reviews, shakedown, and commissioning phases
Ensure efficient allocation of project resources to keep deliverables on track

Skills

Key technologies and capabilities for this role

CQVCommissioningQualificationValidationIQOQPQSOPsDICSVIsolatorsAutoclavesPart WashersFATDesign Reviews

Questions & Answers

Common questions about this position

What qualifications are required for the Senior CQV Engineer role?

Candidates must have a BS or MS in engineering, life sciences, or a related field, 5+ years of CQV experience in life sciences with strong expertise in DI/CSV/security, and familiarity with biotech, aseptic fill/finish, OSD, or gene therapy processes. Strong problem-solving, communication, and customer-focused skills are also required, along with flexibility to travel domestically and internationally.

Is this a remote position or does it require travel?

The role involves working on facilities in Switzerland and the EU with flexibility to travel domestically and internationally as required.

What is the compensation or salary for this position?

This information is not specified in the job description.

What is the company culture like at CAI?

CAI fosters a collaborative, team-first environment where wins are celebrated together, emphasizing values of integrity, teamwork, respect, and a relentless focus on doing what’s right. Every employee is an owner, promoting a diverse and equitable workplace.

What makes a strong candidate for this CQV Engineer position?

A strong candidate will have the must-have qualifications including 5+ years of CQV experience in life sciences with DI/CSV expertise, plus nice-to-have hands-on experience with isolators, autoclaves, or part washers to 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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