Engineer II, Validation
Location:
Lancaster , Pennsylvania
Posted:
April 02, 2017
Reference:
2909170221-en-us

Johnson & Johnson Consumer Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for an Engineer II, Validation to be based in Lancaster, PA.
 
Johnson & Johnson Family of Companies touches more than a billion people’s lives each day through our health care products and services, our corporate giving, and the volunteer efforts of our employees. The Johnson & Johnson Group of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units:  Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and Over-The-Counter (OTC) products.
 
 
The Engineer II, Validation will:
 
  • Lead and execute validation projects at the Lancaster site.
  • Provide technical direction for standards, procedures, risk assessments, and regulatory requirements associated with process and cleaning validation practices and execution.
  • Provide input into the Product Life Cycle process as it relates to validation requirements.
  • Collaborate within the Technical Operations function including Engineering, Solids and Packaging Technology Platforms as well as with Quality functions and the Manufacturing sites to establish and continuously improve process and cleaning validation practices, procedures and performance measures.  Support the site VMP by authoring and/or reviewing sub-volumes, sub-volume supplements and keeping metrics on validation performance measures.
  • Present process and cleaning validation execution strategies, deviations, outcomes and metrics to the site VRC and attend or participate in any other VRC meetings as needed.
  • Ensure that established validation procedures are being followed in all process and cleaning validation executions.
  • With oversight, author standard operating procedures.
  • Execute projects on timelines established by cross functional teams.
  • Offer insight and experiences to help continuously improve validation practices and procedures.
  • Provide metrics on validation performance versus documented plans.
  • Document site validation activities in the validation master plan in a timely manner.
  • Execute validation assessments and protocols.
  • Document Validation activities in reports following required procedures and templates.
  • Supports regulatory agency interactions.
  • Provide technical support to investigations and resolution of process deviations.
  • Identify areas of process improvement.

Qualifications
  • Bachelor’s of Science degree in Chemistry, Pharmacy, Engineering or related technical field is required. 
  • 2+ years of Pharmaceutical manufacturing related experience is required
  • Experience in cleaning validation is preferred. Knowledge of cGMPs and Good Documentation Practices is required.   
  • Must have good verbal, written and analytical skills.
  • Skilled in Microsoft office applications is required.
  • Working knowledge and application of GMP and FDA regulatory requirements and latest guidance in the development, validation, and manufacture of pharmaceutical and OTC products is preferred.
  • Knowledge of Cleaning Validation practices and development is required.
  • Knowledge and application of pharmaceutical/OTC product and process development; life-cycle management for OTC products is preferred.
  • Ability to provide technical leadership in problem-solving and decision-making; to collaborate with and influence business partners with a focus on data, science, and technology is preferred.
  • Strong collaboration, communication, and presentation skills are required.
  • Six Sigma Green Belt certification preferred.
  • This position is based in Lancaster, PA and may require up to 10% travel, both domestic and international.

Primary Location
United States-Pennsylvania-Lancaster
Organization
J & J Consumer Inc. (6101)
Job Function
Process Engineering
Requisition ID
2909170221

A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.

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