Project Lead - AI
Keywords Studios$72,800 - $83,200/year
Full Time
Senior (5 to 8 years)
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Life Sciences, BiotechnologyIndustries
Requirements
Candidates must possess a Bachelor’s or Master’s degree in engineering, life sciences, or a related field. They should have experience in leading and coordinating CQV projects, overseeing equipment qualification activities such as Design Evaluations, Factory Acceptance Testing (FAT), Installation -Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), and developing project plans, schedules, and budgets. Strong documentation management skills, including Test Outlines and Procedures (TOPs), Qualification Summary Reports (QSRs), and change controls, are also required.
Responsibilities
As a Project Manager – CQV Engineer, the individual will lead and coordinate CQV projects, ensuring timely execution and compliance with industry regulations. They will oversee equipment qualification activities, develop project plans and budgets, act as the primary point of contact for stakeholders, manage project documentation, identify and mitigate risks, support continuous improvement initiatives, and ensure adherence to project protocols. Furthermore, they will provide leadership in team meetings, facilitate problem-solving discussions, and manage resource planning for commissioning and validation activities.
Skills
CQV
Validation
Commissioning
FAT
IQ
OQ
PQ
Project Management
Risk Mitigation
Change Controls
FDA Compliance
Equipment Qualification
Project Planning
Quality Control
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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