Validation Specialist

1 week ago

Warren, United States Aequor Full time

Position: Validation Qualification Specialist 58647-1

Location: Warren NJ 07059

Duration: 12+ months (possibility of extension for the right candidate depending on performance)

Pay rate: $51.86/ hour on W2

Job Description: Validation Qualification Specialist

This role is 100% Onsite

Work Schedule: Mon - Fri, Business Hours


1. PURPOSE AND SCOPE OF POSITION:

The Validation Engineer supports the successful implementation of laboratory equipment and systems at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role contributes to the completion of milestones associated with facility, utility, and equipment qualification. With minimum supervision and given general instructions, this individual independently carries out routine tasks and functions and uses basic analytical skills to recognize and solve common problems of limited scope. As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization.


2. REQUIRED COMPETENCIES:

Knowledge, Skills & Abilities:

• Excellent technical writing skills and proficiency with Microsoft Word formatting functions; ability to efficiently create technically accurate documents for system lifecycle deliverables in alignment with the site validation program; highly attentive to spelling, grammar, punctuation, and overall document quality.

• Process-oriented with solid critical thinking skills; adaptive and able to develop new/improved strategies, approaches, and procedures

• Strong understanding of cGXP requirements and good documentation practices relating to systems, equipment, and instrumentation within the pharmaceutical industry.

• Familiarity with 21 CFR Part 11 compliance.

• Knowledge of pharmaceutical laboratory and manufacturing systems, utilities, and facilities. Preferred protocol execution experience with controlled temperature units (Kaye validators, Ellab), biological safety cabinets (cleanroom foggers), cryogenic storage systems, etc.

• Experience writing and executing commissioning/qualification/validation documents including VMP, URS, FAT, SAT, IOPQ, RTM, and summary reports

• Experience writing protocol deviations, investigating out-of-specification results, and performing corrective and preventive actions.

• Ability to interact effectively with cross-functional groups.

• Strong ability to organize assigned tasks in a high-paced environment and concurrently monitor tasks/assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously

• Strong written and verbal communication skills, including solid presentation skills. Proficient at writing well-formulated emails and reports. Ability to follow oral and written instructions, and read and interpret engineering manuals/drawings relevant to the assigned task. Ability to effectively communicate with employees, contractors, and vendors.

• Strong computer skills in Microsoft Office Suite – Word, Excel, and Outlook, and the ability to learn new software as required for equipment qualification.


Competencies:

• Professional Knowledge

• Problem Solving

• Team Player / Building Relationships

• Multi‐tasking

• Customer Focus

• Action and detail-oriented

• Active Listening

• Decisive


3. DUTIES AND RESPONSIBILITIES

1) Maintains all qualified equipment/systems in compliance with policies, guidelines, and procedures:


a. Develops qualification protocols, and associated reports while adhering to a change management process.

b. Supports the execution of equipment/systems qualifications and validation protocols.

c. Supervises vendors for qualification functions.

d. Develops written procedures for calibration and preventive maintenance of equipment and systems.

e. Supports calibration, equipment qualification, and system validation activities.

f. Develop validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, and Change Controls.


2) Manages projects of limited scope and complexity within their functional area:


a. Supports laboratory equipment/systems implementation projects including scheduling, procurement, site prep, installation, qualification, and turnover to the business area.

b. Supports internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment/systems to meet business needs in accordance with required schedules or dates.

c. Completes all calibration, qualification, and validation documentation with accuracy, completeness, and compliance to Client standards.


3) Provides excellent customer service and support:


a. Regularly reviews, prioritizes, and promptly responds to customer equipment qualification/system validation and support requests.

b. Provides technical support and guidance on calibration and equipment qualification issues. Interfaces with customers to ensure all expectations are being met.

c. Maintains a positive relationship with all team members and site customers while promoting a positive team environment.


4) EDUCATION AND EXPERIENCE


a. B.S. degree in Engineering or equivalent required

b. Minimum 5 years of experience in FDA–regulated industry, with 3 years of experience in facility/utility/equipment qualification required.

Additional Job Requirements:

Lab w/o blood & animal

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