CQV Project Manager at CAI

Switzerland

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Life SciencesIndustries

Requirements

BS or MS in a relevant science or engineering field, or equivalent
8+ years of commissioning, qualification, validation, and compliance experience in life sciences or regulated industries
Strong technical knowledge of EU and global regulatory requirements and proficiency in cGMP standards
Experience managing CQV deliverables across one or multiple projects
Skilled in planning and tracking project activities and schedules
Strong interpersonal skills to form relationships with internal teams and external clients
Excellent problem-solving, communication, and customer-focused skills
Familiarity with life science manufacturing processes, including biotech, aseptic fill/finish, OSD, or gene therapy
Flexibility to travel domestically and internationally as required

Responsibilities

Provide cGMP leadership and guidance to integrate and deliver CQV services for life sciences clients
Manage mid-sized to large projects involving process equipment and clean utilities, including start-up and commissioning
Lead design reviews, equipment installation, and site acceptance activities
Write, review, and approve CQV documents in compliance with 21 CFR standards, including SOPs, impact assessments, risk assessments, specifications (URS/FRS/DDS), FATs, SATs, IQ/OQ/PQs, validation protocols, and commissioning test plans
Support onsite and offsite activities such as FATs, SATs, system walkdowns, and execution phases
Manage all aspects of C&Q, including change controls, contractor and vendor coordination, document control, and punch list management
Allocate project resources efficiently and track progress to ensure deliverables meet schedules

Skills

Key technologies and capabilities for this role

cGMPCQVFATSATIQOQPQURSFRSDDSSOPRisk Assessment21 CFRChange ControlProject Management

Questions & Answers

Common questions about this position

What education and experience are required for the CQV Project Manager role?

A BS or MS in a relevant science or engineering field (or equivalent) and 8+ years of commissioning, qualification, validation, and compliance experience in life sciences or regulated industries are required.

Is travel required for this position?

Yes, flexibility to travel domestically and internationally as required is needed.

What is the salary or compensation for this role?

This information is not specified in the job description.

What does the company culture look like at CAI?

CAI fosters a collaborative, team-first environment with values of integrity, teamwork, respect, and a focus on doing what's right, where every employee is an owner and successes are celebrated together.

What makes a strong candidate for this CQV Project Manager position?

Strong candidates have strong technical knowledge of EU/global regulations and cGMP, experience managing CQV deliverables across projects, excellent interpersonal, problem-solving, and communication skills, plus familiarity with life science manufacturing processes.

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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