Staff Engineer, Validation
Location:
Lancaster , Pennsylvania
Posted:
April 02, 2017
Reference:
9195161026-en-us

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.
 
Johnson & Johnson Consumer Inc., a member of Johnson & Johnson’s family of companies, is recruiting for a Staff Engineer, Validation to be based in Lancaster, PA.
 
The Staff Engineer, Validation will:
  • Lead and execute validation projects at the Lancaster site.
  • Provide technical leadership and direction for standards, procedures, risk assessments, and regulatory requirements associated with 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, Liquids, Solids and Packaging Technology Platforms as well as with Quality functions and the Manufacturing site to establish and continuously improve 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 validation execution strategies, deviations, outcomes and metrics to the site VRC and attend or participate in any other VRC meetings as needed.
  • Maintain technical training/knowledge in applicable functional area.
  • Consult literature to aide in solutions for technical problems.
  • Maintain in depth knowledge of state of current validation practices across industry.
  • Ensure that established validation procedures are being followed in all validation executions.
  • Participate in establishing consistent, harmonized, validation processes and procedures across the McNeil Consumer Healthcare Division OTC businesses and manufacturing sites.
  • Participate in J&J Enterprise forums on validation standards and guidelines.
  • Author/approve as technical SME standard operating procedures.
  • Participate in cross-functional teams to lead and execute projects as well as continue improvement in validation practices and procedures.
  • Be responsible to ensure the site validation activities are documented in the Validation Master Plan consistently and on a timely basis.  Provides metrics on performance versus the documented plans.
  • Inform Management of validation state and issues requiring prioritization.
  • Lead, execute and/or review the progress of approved projects.  Provide ideas and support to resolve issues impacting timely completion and achievement of project goals.
  • Document Validation activities in reports following procedures and templates.  Reviews validation documentation for content and GDP. Approves validation documentation.
  • Participate in audits.  Support regulatory agency interactions.
  • Provide technical support to investigations and resolution of process deviations including complex investigations.
  • Identify areas of process improvement.  Work with technical group to implement process improvements.  Leads process improvement initiatives.
  • Influence the direction of projects and resources as indicated through collaboration with business partners, manufacturing sites and site validation efforts.
  • As applicable provide supervision and/or guidance to engineers with less experience.
  • Lead cross functional teams working on validation projects.
  • Oversee the work of contractors.
  • Works under limited supervision.

Qualifications
  • A  Bachelor’s of science degree in Chemistry, Pharmacy, Engineering or Science is required. 
  • 6+ years of Experience in Pharmaceutical manufacturing is required.
  • Experience in validation is required.
  • Relevant experience engineering, technical, and/or operations areas is required.
  • Knowledge of cGMPs and Good Documentation Practices is required.
  • Experience working in FDA/cGMP compliance environment required.
  • In depth knowledge and application of FDA and ICH regulatory requirements and latest guidance in the development, validation, and manufacture of pharmaceutical and OTC products preferred.
  • Ability to collaborate with and influence manufacturing site leadership teams regarding prioritization and resourcing is preferred.
  • Ability to inform, communicate with, and influence Senior Management regarding validated state of respective products/processes and indicated priorities is preferred.
  • Knowledge and application of pharmaceutical/OTC product and process development; life-cycle management of this class of products including strategies for continuous improvement preferred.
  • Ability to direct multiple projects concurrently; to periodically assess and re-direct resources as indicated in a dynamic environment preferred.
  • Ability to provide technical leadership in problem-solving and decision-making; to collaborate with and influence business partner leaders with a focus on data, science, and technology preferred.
  • Ability to constructively challenge cross-functional project teams and business partners to achieve project goals and McNeil strategic plans preferred.
  • Strong collaboration, communication, and presentation skills required.
  • Six Sigma Green Belt and/or Black certification preferred.
  • This role is based in Lancaster, PA and may require up to 10% travel based on business needs.

Primary Location
United States-Pennsylvania-Lancaster
Organization
J & J Consumer Inc. (6101)
Job Function
Engineering (Generalist)
Requisition ID
9195161026

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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