Validation Engineer at CAI

Boulder, Colorado, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Life SciencesIndustries

Requirements

Bachelor’s degree (BS/BA) in Engineering, Chemistry, or Life Sciences (relevant experience can substitute for education)
2+ 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 Other

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

CQVCommissioningQualificationValidationSOPsDocumentation ReviewComplianceSafety ProtocolsProject SchedulingProgress Tracking

Questions & Answers

Common questions about this position

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

Candidates need a Bachelor’s degree in Engineering, Chemistry, or Life Sciences (or relevant experience substituting), 2+ years in the Pharmaceutical/Life Sciences industry, essential GMP experience, outstanding communication skills, strong problem-solving, a customer-focused mindset, and willingness to travel throughout the U.S.

What is the salary for this Validation Engineer position?

This information is not specified in the job description.

Is this Validation Engineer role remote or onsite, and what is the location?

This information is not specified in the job description.

What is the company culture like at CAI?

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

What makes a strong candidate for this Validation Engineer position?

Strong candidates have GMP experience in pharma/life sciences, a relevant degree or equivalent, proven CQV execution skills, excellent communication and problem-solving, and flexibility for U.S. travel.

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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