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, 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. 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 BMS 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 Sills: Validation - Commissioning/Qualification Specialist / Specific Commissioning and Validation support