Equipment Qualification Specialist

2 weeks ago

Akron, Ohio, United States TSR Consulting Full time

About TSR:
TSR is a relationship-driven, client-centric IT and technical services staffing organization.
For over 40 years, TSR, Inc.

and its wholly owned subsidiary, TSR Consulting Services, have thrived in the Information Technology staffing sector, earning the trust of both large and small enterprises through well-honed candidate evaluation, timely placements, and a genuine understanding of the essential skill sets required by our clients.

Mission & Vision
We focus on constructing a company around our vision, which is simply;
Every employee's input is valued, their contributions are recognized, and their skills are rewarded.
We challenge each team member daily to elevate the standards of how we engage with our consultants and candidates.

For too long in this industry, candidates have faced neglect, misinformation, or have been placed with clients and subsequently forgotten.

Our team diligently works each day to qualify and place top talent with our clients in a compassionate and respectful manner.

While not every candidate may fit the role, every individual will be treated with dignity and professionalism.

Equipment Qualification Specialist
Job Description

Location:
Summit, New Jersey

Type:
Contract

Job #79372
Our client, a prominent pharmaceutical organization, is seeking an

Equipment Qualification Specialist

on a contract basis.

Job ID #: 79372

Work Location:
Summit, NJ - 100% Onsite

Summary:


The Equipment Qualification Specialist is responsible for facilitating the effective implementation of various process and laboratory equipment at multi-use sites through collaboration with internal stakeholders and external service providers.

The individual in this role is tasked with the commissioning and qualification of new equipment, facilities, utilities, and ensuring that equipment systems are maintained in a qualified/validated state in accordance with established policies and procedures.

This role involves participation in projects and ongoing work activities of low to moderate complexity.

With minimal supervision and general instructions, this individual will execute routine tasks and functions, employing basic analytical skills to identify and resolve common issues of limited scope.

As a developing team contributor, the individual will interact with their immediate supervisor and colleagues within their work group to achieve team objectives while fostering trust and collaborative relationships beyond their immediate organization.


Knowledge/Skills/Education:
A Bachelor's degree in Engineering or a related scientific discipline is required.
A minimum of 5 years' experience in performing/supporting activities within a GMP environment.
At least 3 years' experience in the qualification of equipment, facilities, or utilities.
Familiarity with cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements, and good documentation practices.
Experience in the qualification of cell therapy equipment is advantageous.
Advanced understanding of pharmaceutical, manufacturing, and laboratory systems.
Knowledge of investigations, deviations, and CAPA management in a regulated pharmaceutical environment.
Strong written and verbal communication skills.
Excellent interpersonal skills with experience engaging with a diverse workforce.
Proven ability to multitask alongside strong organizational skills.

Capability to prioritize assigned tasks in a fast-paced environment while concurrently monitoring tasks/assignments with others that may affect timely completion.

Proficient in managing multiple tasks and activities simultaneously.

Highly skilled in Microsoft Office Suite - Word, Excel, PowerPoint, and Outlook, with extensive experience in database systems.

An innate ability to learn new software, such as corporate intranet and enterprise business systems.


Responsibilities:
Maintain qualified equipment systems in compliance with policies, guidelines, and procedures:

Develop qualification protocols and associated reports while adhering to a change management process.
Support the execution of equipment qualifications and validation protocols.
Oversee vendors for qualification functions.
Create written procedures for calibration and preventive maintenance of equipment.
Assist in equipment qualification and validation activities.
Generate validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, and Change Controls.
Manage projects of limited scope and complexity within their functional area:

Support equipment implementation projects, including scheduling, procurement, site preparation, installation, qualification, and turnover to the business area.

Assist internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules.

Ensure all qualification and validation documentation is completed with accuracy, completeness, and compliance with company standards.

Provide excellent customer service and support:
Regularly review, prioritize, and promptly respond to customer equipment qualification and support requests.
Offer technical support and guidance on equipment qualification issues. Engage with customers to ensure all expectations are met.
Provide technical support and guidance on equipment and computer systems qualification and validation issues.
Maintain positive relationships with all team members and site customers while promoting a collaborative team environment.
Regulatory

Responsibilities:
Ensure equipment, facilities, and programs are maintained in compliance.
May be called upon as a Subject Matter Expert in both internal and regulatory audits.

Working Conditions:
Occasional stooping, bending, stretching, pushing, pulling, reaching, and/or lifting up to 25lbs.
Ability to sit, stand, walk, and move within the workspace for extended periods.
Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing, and pulling.

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