Senior Validation Engineer at CAI

Charlottesville, Virginia, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, PharmaceuticalsIndustries

Requirements

Bachelor’s degree (BS/BA) in Engineering, Chemistry, or Life Sciences (relevant experience can substitute for education)
3+ years of related experience in the Pharmaceutical/Life Sciences industry
Essential experience in a GMP (Good Manufacturing Practice) environment
Outstanding oral and written communication skills
Strong problem-solving abilities
Customer-focused mindset
Willingness and flexibility to travel throughout the U.S. and potentially internationally
Critical competencies: Influence Strategy, Satisfy the Customer, Plan for Success, Pursue Execution, Tailor Communication, Build Partnerships, Influence Others

Responsibilities

Perform Commissioning, Qualification, and Validation (CQV) activities with a strong focus on safety
Deliver C&Q activities in alignment with project schedules
Track and report progress of CQV efforts
Support the generation and review of C&Q procedures for client projects
Review and revise qualification-related documents, including SOPs, master plans, and execution plans
Assist with CQV review and qualification of equipment design
Support planning of commissioning spares and consumables
Allocate project resources for efficient execution
Coordinate support and logistics during CQV execution
Support execution of design reviews, equipment shakedown, commissioning, FATs, IQ, OQ, and PQ activities
Coordinate with project contractors and equipment vendors to execute required testing

Skills

Key technologies and capabilities for this role

CQVCommissioningQualificationValidationSOPsMaster PlansDocumentation ReviewProject SchedulesSafety Protocols

Questions & Answers

Common questions about this position

What qualifications and experience are required for the Senior Validation Engineer role?

Candidates need a Bachelor’s degree in Engineering, Chemistry, or Life Sciences (or relevant experience substituting), 3+ years in the Pharmaceutical/Life Sciences industry, essential GMP environment experience, outstanding communication skills, strong problem-solving, customer-focused mindset, and willingness to travel.

Is travel required for this position?

Yes, the role requires willingness and flexibility to travel throughout the U.S. and potentially internationally.

What is the salary or compensation for this role?

This information is not specified in the job description.

What are CAI's foundational principles and company culture like?

CAI emphasizes acting with integrity, serving each other and society, working for the future, relentless dedication to excellence, bold thinking, creativity, and operational readiness as a way of life.

What makes a strong candidate for this Senior Validation Engineer position?

A strong candidate has 3+ years in Pharma/Life Sciences with GMP experience, a relevant degree or equivalent, excellent communication and problem-solving skills, a customer-focused approach, and flexibility for travel, along with hands-on CQV execution expertise.

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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