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Validation Specialist

Kelly Services


Location:
Wilson, NC
Date:
04/19/2018
2018-04-192018-05-19
Job Code:
US41L8LR_BH1426919
Categories:
  • Engineering
Kelly Services
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Job Details

Job Title Validation Specialist

Jobid US41L8LR_BH1426919

Location: Wilson, NC, 27896, USA

Description **Cleaning Validation Expert - Wilson, NC**

**_Kelly Services is currently hiring a Cleaning Validation Expert for a long term contract opportunity at a prestigious multinational pharmaceutical organization._**

**Duration** : 12 Months

**Pay Information:** Negotiable

**Job Purpose:**


+ Executing and managing process, primary packaging, and cleaning validation activities and change
+ Management activities to meet cGMP requirements on time and quality to ensure that site validation programs
+ Are compliant with global regulatory expectations
**Major Accountabilities:**

Stewardship:


+ Support Product Steward in maintaining the process control strategy.
+ Translate applicable process parameters and the process control strategy into a focused validation plan for process validation.
+ Provide technical expertise and facilitate establishment of Quality Risk Assessment (as needed).
**Validation** :


+ Support site validation planning by writing and maintaining master plans for processes, cleaning, packaging processes and ongoing verification for processes and cleaning (as applicable).
+ Support process validation lifecycle activities by ensuring a state of control is maintained through ongoin process verification (OPV).
+ Ensure that appropriate variables are identified for on-going monitoring as a contributor to quality risk management activities.
+ Author and review process, packaging or cleaning validation protocols & reports, ongoing process and cleaning verification protocols & reports.
+ Support execution of validation activities at the shop floor.
+ Support validation lead for KPI reporting.
+ Reviews Master Batch Records and associated change controls. Confirm revalidation need
+ Maintain all activities and projects under own responsibility in an inspection ready status.
+ Provides technical expertise (and may facilitate) pre-validation risk assessments using risk management tools.
+ Work collaboratively and cross functionally to help ensure that process risks are analyzed, appropriately controlled and appropriately documented.
+ Ensure that all Site validation activities are performed and are in line with the current Novartis requirements and cGMP, manage deviations associated with process validation and makes recommendations for deviation resolution as well as prevention of reoccurrence.
**Launch & Transfer:**


+ Work in close collaboration with development organization (or sending site) for technical transfers and new product launches to ensure that knowledge is transferred, control strategies are appropriate, risks are analyzed and controlled and to ensure that commercial processes are validation ready
+ Participate in pre-validation activities and risk assessments to ensure the success of commercial process validation.
**Skills** :


+ 2-3 year experience in manufacturing/ manufacturing science and technology/technical development/quality.
+ Thorough understanding of manufacturing processes and related process equipment.
+ Strong working knowledge of quality systems and regulatory requirements across multiple health authorities.
+ Experience in executing process validation.
+ Expert in reviewing and writing technical reports.
+ Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions).
+ Fundamental understanding of standard pharmaceutical analytical testing.
**Education** :

BSc. in Chemistry, Pharmacy, Chemical Engineering or Pharmaceutical Technology.

**Required Skills:**

ANALYTICAL TESTING

PRODUCT/PROCESS VALIDATION

**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. Please apply online or contact luisa.ruthner@kellyservices.com for immediate consideration.

**Why Kelly** **®** **?**


With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the worlda better place. Let Kelly fuel your career—connect with us today.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connectwith us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.



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