Validation Engineer II

Please Contact: To discuss this amazing opportunity reach out to our Talent Acquisition Specialist Priyanka Mahant at email address @ can be reached on # .

We have Contract role Validation Engineer for client at Carlsbad CA . Please let me know if you or any of your friends would be interested in this position.

Position Details:

Validation Engineer - Carlsbad CA

Location : Carlsbad CA 92008 (On-site)

Project Duration: 06 Months of contract

Shift : 8:00 AM - 5:00 PM (Mon-Fri)

Pay Rate : $48.00 per hour on W2

Job Description:

Responsible for creating and implementing the Abbott Division validation program.

Creates and maintains validation documentation for new and existing systems and processes subject to design control.

Ensures that validation activities are implemented for systems and processes used to manufacture control and store intermediates and finished products to requirements and standards as listed in the current Quality Systems Manual.

Main Responsibilities:

Develop and execute validation strategies for GMP facilities utilities process equipment analytical instruments and laboratory systems

Author and execute Validation Master Plans (VMPs) equipment validation plans and qualification strategies using a risk-based approach aligned with internal procedures and regulatory expectations

Manage VMPs and associated reports related to new product development and existing production processes systems and controls

Develop and/or review User Requirements Specifications (URS) functional requirements risk assessments and Requirements Traceability Matrices (RTMs) for new and existing systems

Author protocols for Process Validations and Facilities Utilities Equipment and/or analytical instrumentation qualification including Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) Engineering Study Protocols (ESPs) and associated lifecycle documentation against production processes and systems in compliance to internal and external requirements utilizing well developed technical and regulatory skills

Lead or support execution of IQ OQ PQ Test Method Validation (TMV) Engineering Studies and Process Validation activities for manufacturing processes facilities utilities and equipment

Manage the execution of validation protocols as protocol directors in assurance of timely and cost-efficient completion through specialized experience and training

Evaluate validation results of validation protocol executions employing specialized experience and training

Consult with owner/user groups to summarize validation results in final reports incorporating strong communication skills and experience

Support equipment commissioning installation verification startup activities and turnover into GMP operation for manufacturing and laboratory systems

Perform validation assessment on Change Management documentation including but not limited to document changes system changes and process changes

Track and report validation progress of corporate validation projects through departmental project tracking tools

Evaluate qualification and validation results investigate deviations and validation events author validation event reports (VERFs) and implement corrective actions as required

Represent Abbott Division during internal and external audits of validation projects and documentation

Present validation and qualification status results and release recommendations during project reviews

Cultivates a wide range of internal networks and begins to develop an extensive external network of resources to facilitate completion of tasks

May lead a project team of moderate scope

Provides guidance to less experienced staff

Acts as a mentor to lower-level individual contributors

Influence exerted at peer level and occasionally at first levels of management

Plans organizes and prioritizes own daily work routine to meet established schedule

Execises authority and judgment within defined limits to determine appropriate action

Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules and may result in the allocation of additional resources

Qualifications:

Education Level Major/Field of Study or Equivalent

Bachelors Degree in related field

Masters Degree Preferred

Preferred Experience and Technical skills:

Strongly preferred experience in one or more of the following areas:

Qualification and validation of GMP manufacturing equipment used in oligonucleotide biologics or biotechnology manufacturing environments

Hands-on experience serving as validation lead qualifying analytical instrumentation including Agilent HPLC systems (Open Lab CDS) chromatography data systems spectrophotometers and other laboratory analytical equipment

Experience qualifying and validating automated purification systems including Cytiva ÄKTA Pure ÄKTA Go ÄKTA Flux tangential flow filtration (TFF) and chromatography platforms utilizing UNICORN software

Experience with oligonucleotide synthesis equipment such as Cytiva ÄKTA Oligo Synt or similar automated synthesis platforms

Demonstrated experience independently planning and leading commissioning qualification and GMP readiness activities for new manufacturing facilities cleanrooms laboratories utilities process equipment and infrastructure systems

Demonstrated experience independently developing and executing validation strategies and lifecycle documentation for GMP facilities utilities equipment and manufacturing processes including Validation Master Plans (VMPs) User Requirements Specifications (URS) Requirements Traceability Matrices (RTMs) risk assessments IQ/OQ/PQ protocols engineering studies process validation protocols validation reports and final validation turnover packages

Experience managing validation through the full lifecycle from commissioning and qualification planning through equipment release process validation change control deviation investigations and ongoing validated-state maintenance

Experience collaborating with equipment vendors during commissioning and qualification activities including evaluating vendor documentation to develop wrapper protocols aligning with site qualification standards and Quality Management System requirements

Experience/Background Details:

Minimum 2-3 years of related work experience with a good understanding of specified functional area.

Working technical knowledge and application of concepts practices and procedures.

General understanding of business unit/group function.

Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.

Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors.

Exercises judgment within defined procedures and practices to determine appropriate action.

Has a broad knowledge of technical alternatives and an understanding of their impact on the systems environment.

To discuss this amazing opportunity reach out to our Talent Acquisition Specialist Priyanka Mahant at email address @ can be reached on # .

About generis tek: generis tek is a boutique it/professional staffing based in Chicago land. We offer both contingent labor & permanent placement services to several fortune 500 clients nationwide. Our philosophy is based on delivering long-term value and build lasting relationships with our clients consultants and employees. Our fundamental success lies in understanding our clients specific needs and working very closely with our consultants to create a right fit for both sides. We aspire to be our client has most trusted business partner.