Validation - Commissioning/Qualification Specialist

Company: Artech LLC
Location: Warren
Posted on: March 14, 2023

Job Description:

Job Description: Qualification Specialist
This role is 100% Onsite at the Warren, NJ site
Work Schedule is Mon - Fri, Business hours

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.

REQUIRED COMPETENCIES:
Knowledge, Skills & Abilities:
--- Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry.
--- Required experience with temperature mapping of incubators, refrigerators, freezers, and other controlled chambers using Kaye Validator or equivalent
--- Required experience with common equipment, such as water bath, balances, and centrifuges
--- Knowledge of pharmaceutical laboratory and manufacturing systems. Preferred experience with BSCs, welders, and sealers
--- 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 Client 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

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.
1. PHYSICAL /MENTAL DEMANDS: (US Only)
--- This involves physical or mental exertion produced by the incumbent carrying out the responsibilities of the position beyond a standard office environment.
--- This may include sitting, standing, walking, bending, crawling, climbing, reaching, kneeling, balancing, pushing, pulling, talking, repetitive motion, grasping, lifting (specify weight), or carrying (specify weight).
--- This may also include concentrating, remembering names, distinguishing colors, effective verbal and/or written communication, analytical thinking, decision making, and adapting to change.
2. ENVIRONMENTAL CONDITIONS: (US Only)
--- Environment may include working in office or in a laboratory / manufacturing area.
--- Ability to work safely in an environment with hazardous, radioactive, and infectious materials and waste.
--- Ability to work safely when working alone, or working with others.

Keywords: Artech LLC, Elizabeth , Validation - Commissioning/Qualification Specialist, Other , Warren, New Jersey