Aequor Technologies Inc, is an US based IT consulting and solutions company, providing high value services to leading customers for over a decade. We have over 7 centers in the US and 2 Technology Development Centers in Asia. Please visit www.aequor.com for additional information

Provide risk assessment for new computer systems and changes to existing computer systems

Write validation plans, protocols and reports 

Execute and provide reviews of validation protocols and validation periodic monitoring

Lead or participate in project team including the supervision of validation contractors

Plans and executes validation aspects of computer system project portfolio

Provides project estimates of validation resource requirements

Supports audits and inspections related to computer systems

Greater than 10 years of relevant cGMP biopharmaceutical manufacturing environment experience in computer system validation.

At least 5 years must be recent experience with validation of typical GMP manufacturing computer systems at a pharmaceutical manufacturing facility.

Experience leading computer system validation projects in a GMP environment

Experience supporting at least three of the following business-process supporting technology platforms: MES, LIMS, Lab Systems, quality systems (change control, deviation, CAPA), document management, training

Deep technical knowledge of enterprise computer systems (IT infrastructure, software design, software development, system architecture, distributed systems, system integration, and/or software maintenance)

Knowledge of validation lifecycle approach and international regulatory requirements

Validation experience using risk based approach

Outstanding technical writing and verbal communication skills

Ability to work as part of a high performing team and collaborate effectively with staff at all levels. Must have well-developed interpersonal skills with the ability to establish highly functional relationships with diverse personalities both within and outside the company.

Demonstrated ability to manage multiple activities while maintaining a high level of organization

Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision.

Experienced in Microsoft Office Suite

Education

Bachelor’s Degree in computer science, computer engineering, information technology, life science or engineering, from an accredited university or college.

Thank you,

Aman Parkash Singh

Direct Line number :  732-979-2581