30 days old

Sr. Validation Engineer

Kelly Services
Summit, NJ 07901
Kelly Services is seeking a **Sr. Validation Engineer** for one clients in the pharmaceutical industry in **Summit, NJ.**

**This is a 5 month contract and pay is negotiable**

**Purpose and Scope of Position**

The Sr. Validation Engineer supports the successful implementation of equipment/utilities/facility/lab instruments at multi-use sites through interaction with internal customers and external service providers.

The incumbent in this is tasked with commissioning and qualifying new equipment facilities, utilities and maintaining equipment systems in a qualified / validated state according to established policies and procedures.

The individual participates in projects and ongoing work activities of low to moderate complexity.

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.

Duties and Responsibilities:

1) Maintains 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 qualifications and validation protocols.

c. Supervises vendors for qualification functions (as needed)

d. Supports equipment qualification and validation activities.

e. 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 equipment 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 to meet business needs in accordance with required schedules or dates.

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

3) Provides excellent customer service and support:

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

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

c. Provides technical support and guidance on equipment and computer systems qualification and validations issues.

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

4) Regulatory Responsibilities

a. Ensure equipment, facilities and programs are maintained in compliance.

May be called upon as SME in both internal and regulatory audits

Required Competencies: Knowledge/ Skills, and Abilities:

Knowledge of 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 a plus

Advanced knowledge of pharmaceutical, manufacturing and laboratory systems, including computerized/automated systems

Strong knowledge of CSV principles

Understanding of investigations, deviations and CAPA management in a regulated pharmaceutical industry.

Strong written and verbal communication skills

Excellent interpersonal skills with experience dealing with a diverse workforce

Strong multi??tasking ability in conjunction with proven organizational skills. 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

Highly proficient computer skills in Microsoft Office Suite Word, Excel, PowerPoint and Outlook with extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business

Education and Experience:

BS in Engineering or Science related discipline preferred

Minimum of 7 years experience performing/supporting activities in a GMP environment

Minimum of 5 years experience in equipment, facility or utility qualification

Working Conditions:

Primarily office based, but some on floor/clean room interactions may be required

Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions

Reagents, chemicals, and exposure to sanitization agents could be expected

Potential exposure to human blood components and strong magnets

Designated clean room areas will prohibit food, any outside materials such as cell phones, tablets, at a minimum

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management

**Why Kelly** **** **?**

As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.

**About Kelly** ****

At **Kelly** , were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

Posted: 2020-08-21 Expires: 2020-09-21

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Sr. Validation Engineer

Kelly Services
Summit, NJ 07901

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