CenterWatch

1+ months

Validation Engineer

Kelly Services
Marion, NC 28752
**Job Details:**



**Industry:** Pharmaceutical



**Work Location:** Marion, NC



**Job Title:** **Validation Engineer**



**Duration:** 9 Months (Temporary/Contract)



**RESPONSIBILITIES**

Provide hands on validation support to several facility/utility and equipment qualifications that are planned for the site. This validation engineer will need to have experience with qualification in HVAC, Clean Room Qualifications, Compressed Air, and Water for Injection systems.


Responsibilities:

Must perform process validation, process capability, and process control studies for assigned areas

Must support Manufacturing, Engineering, and Quality Management departments with the development and implementation of new process/technology.

Must participate in and contribute to medium to large size projects, own assigned tasks, produce detailed requirements and analysis documents for assigned tasks. Partner with other support groups and manufacturing teams to complete work.

Must ensure computer systems and applications follow regulatory quality standards through validations activities.

Responsible for creating the documents required for the development and validation of computerized systems.

Must be able to understand, test, and debug applicable software while following the software life cycle procedures.

Responsible for ensuring FDA regulations are met for system upgrades/replacements.

Responsible for ensuring the quality of facility systems (validation):

o Writing and executing protocols and test cases for validations.

o Coordinating testing and documentation of projects.

o Documenting/executing changes to applications.

o Assisting/leading training for systems.

o Develop test requirements, and prepare and document test data for complex system testing.

o Provide support to resolve technical issues with systems under validation

Ability to function effectively as a member of a team.

Ability to communicate effectively in written and verbal form.

Must perform all other duties and responsibilities as determined by supervision/management.

This position will be implementing software driven system while working with engineering and IT.

The basic understanding of software systems and how to appropriately test is mandatory.


QUALIFICATIONS:

BS degree in Engineering Discipline (ME, IE, CHE, BME, EE, CE) with at least 3-5+ years of experience.

Knowledge of applications such as MS Office: Word, Excel, PowerPoint, Outlook, Microsoft Project (nice to have).

Wonderware, Allen-Bradley PLC, nice to haves but not required

Experience with installation, administration, and maintenance of servers is helpful

Leadership skills.

Logical thought process.

Ability to work with diversified cross functional team across different plant locations.

Self-motivated and work well without direct supervision.

Ability to quickly learn and understand applications.

Quality Assurance or Pharmaceutical industry experience desired.

Candidates must meet visual acuity requirements as documented

Validation experience must focus around commissioning and qualifications.

IQ / OQ / PQ & Data Integrity (ALCOA)

Must have pharmaceutical or medical device experience

Soft Skills: Critical thinker, self-starter, team player, sense of urgency, engaged, solution oriented

It will be important for the individual to be able to work days, nights, holidays, and/or weekends as needed by the project timeline to meet manufacturing deadlines.


Physical Requirements (Large manufacturing site)

Requires continuous grasping, pushing/pulling up to 15 pounds and reaching with hands and arms.

Lifting and carrying on average up to 15 pounds frequently throughout the shift.

Normal visual acuity and the ability to distinguish color are necessary.

Have the ability to complete quick and precise repetitive processes using both arms and both hands

Occasionally specialized physicals are required when working with certain drug codes.

Must be able to squat, climb, reach above shoulder level, reach at or below shoulder level, kneel, twist and bend at the neck, twist and bend at the waist and balance




**Why Kelly?**




+ As a Kelly Services employee, you will have access to numerous perks, including:

+ Exposure to a variety of career opportunities as a result of our expansive network of client companies

+ A competitive hourly pay rate with weekly checks

+ Access to newly expanded Medical Plan options

+ Online continuing education via the Kelly Learning Center

+ Several employee discounts

+ And more!





**Apply Today!**



**Important information:** This position is recruited by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States.







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



Kelly puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm with an unmatched reputation for quality, integrity, and professionalism. Whether you seek the variety and flexibility of working on short-term project engagements or prefer contract-to-hire or direct-hire placement with our clients, apply with Kelly to explore opportunities that suit your specific professional interests.




**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: 2019-09-16 Expires: 2019-11-16

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Validation Engineer

Kelly Services
Marion, NC 28752

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