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Computer Systems Validation with Equipment Validation Experience

Alpha Consulting Corporation

Location:
West Chester, OH
Posted Date:
7/2/2014
Position Type:
Contract, Part time
Job Code:
14-00658
Salary:
Required Education:
High school or equivalent
Areas of Expertise Desired:
Pharmaceutical, Validation,

Job Description

COMPUTER SYSTEMS VALIDATION WITH EQUIPMENT VALIDATION EXPERIENCE

REQUIREMENT #14-00658
RECRUITER:  BRIDGET BURNS
JOB LOCATION:  WEST CHESTER, OH
JULY 2, 2014

*** CANDIDATES MUST BE ABLE TO WORK ON OUR PAYROLL AS A W-2 ***

Project Description:  Develop facility, equipment, analytical, and computer validation plans. Prepare validation protocols (IQ, OQ, PQ).

Responsibilities:
•   Coordinate the proper approval of plans and protocols. Perform the execution of protocols.
•   Prepare validation final reports
•   Support the QA department in any regulatory inspections or audits
•   Work with QA to track and coordinate re-qualification events
•   Document deviations, system failures, and corrective actions
•   Generate validation protocols (e.g. Val Plans, Requirements, final reports, Traceability Matrix, and Retirement Plans) per approved policies and procedures
•   Apply a risk-based approach to develop validation strategies based on the intended use of a new or existing system
•   Execute approved validation protocols (e.g. IQ, OQ, PQ) and document deviations, system failures, and corrective action
•   Review completed protocols for completeness, cGxP compliance, and data acceptability
•   Ensure GxP systems remain in a validated state by reviewing proposed change controls, evaluating impact, generating testing to verify the system still functions as expected
•   Resolve comments, deviations, and technical issues. Support the Quality department in any regulatory inspections or audits
•   Support change control, configuration management systems, and re-validation events
•   Able to plan and schedule validation projects
•   Coordinate validation execution between all involved departments

Qualifications:
•   BS or MS in Engineering, Life Science, or Computer Sciences
•   5+ years validation experience in an FDA validated environment
•   Prior experience in cleaning, computer, and / or automation validation strongly preferred
•   Broad validation experience to support multiple functional areas within a pharmaceutical manufacturing facility
•   Ability to interface, lead, and communicate with multiple groups
•   Works independently and follows stringent timelines
•   Knowledgeable in cGLPs, cGCPs, cGMPs, validation principles and changes controls
•   Proficient in the use of Microsoft Word, Excel, Outlook, and Project
•   Excellent written and verbal communication skills
•   Detail oriented with a focus on quality and metrics
•   Flexible and able to work in a team environment
•   Excellent written and verbal communication skills


Requirements:
Physical Demands: Ability to work a flexible schedule to support a 24/7 facility. Ability to sit for long periods of time reviewing and generating electronic and written data. Requires ability to transport up to approx 20 lb of equipment or documentation.

Manual Dexterity:  Frequently use a computer keyboard, PDA, or other electronic device. Calibrate small components on machines or equipment. Ability to operate complex automated equipment.

Audible / Visual Demands:  Ability to accurately interpret sounds and associated meanings at volume levels consistent with interpersonal or group conversations. Ability to interpret the letters and numbers when viewed on a personal computer screen, PDA, reports and other documents. Ability to distinguish between colors (e.g. warning lights on equipment).  Ability to view and interpret screens / HMIs for entire shift. Hear audible equipment alarms.

Environment:  Manufacturing, Office, and Lab environments including clean rooms and chill rooms




This 12+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.com

Requirements

Qualifications:
•   BS or MS in Engineering, Life Science, or Computer Sciences
•   5+ years validation experience in an FDA validated environment
•   Prior experience in cleaning, computer, and / or automation validation strongly preferred
•   Broad validation experience to support multiple functional areas within a pharmaceutical manufacturing facility
•   Ability to interface, lead, and communicate with multiple groups
•   Works independently and follows stringent timelines
•   Knowledgeable in cGLPs, cGCPs, cGMPs, validation principles and changes controls
•   Proficient in the use of Microsoft Word, Excel, Outlook, and Project
•   Excellent written and verbal communication skills
•   Detail oriented with a focus on quality and metrics
•   Flexible and able to work in a team environment
•   Excellent written and verbal communication skills


Requirements:
Physical Demands: Ability to work a flexible schedule to support a 24/7 facility. Ability to sit for long periods of time reviewing and generating electronic and written data. Requires ability to transport up to approx 20 lb of equipment or documentation.

Manual Dexterity:  Frequently use a computer keyboard, PDA, or other electronic device. Calibrate small components on machines or equipment. Ability to operate complex automated equipment.

Audible / Visual Demands:  Ability to accurately interpret sounds and associated meanings at volume levels consistent with interpersonal or group conversations. Ability to interpret the letters and numbers when viewed on a personal computer screen, PDA, reports and other documents. Ability to distinguish between colors (e.g. warning lights on equipment).  Ability to view and interpret screens / HMIs for entire shift. Hear audible equipment alarms.

Environment:  Manufacturing, Office, and Lab environments including clean rooms and chill rooms

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