Validation Qualification Specialist/ Technical Writer

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 equipment qualification and computer system validation. With minimum supervision and given general instructions, this individual 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 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. Preferred experience with Kaye validators, BSCs, refrigerators, welders, etc.
- Experience executing equipment qualification documents.
- Ability to interact effectively with laboratory, QA, and Facilities 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 along solid presentation skills. Proficient at writing well-formulated emails and reports. Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task. Ability to effectively communicate with employees, contractors and vendors. Experience with technical writing and document development / generation
- 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
- Multitasking
- 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. Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, 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 turn over to 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.
b. Minimum 5 years of experience in FDA - regulated industry, with 3 years of experience in equipment qualification and computer system validations.
Additional Job Requirements:
None