HireDiversity

Fort Washington, PA, US

Director Process Engineering and Validation — OTC Liquids-5066121212

Description

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc is currently recruiting for a Director of Process Engineering and Validation - OTC Liquids located in Fort Washington, PA.

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc markets a broad range of over-the-counter products, including TYLENOL® acetaminophen products, ZYRTEC® and BENADRYL® allergy medicines, IMODIUM® A-D anti-diarrheal, MOTRIN® IB, and SUDAFED® nasal decongestants.

The Director, Process Engineering and Validation (PE&V) will provide leadership and direction for a department of technical resources contributing to key business goals for McNeil Consumer Healthcare and the J&J Consumer Supply Chain. This individual will lead and partner with Operations, Manufacturing sites, Quality Assurance, and Compliance to identify, define, prioritize, and execute projects impacting compliance, cost, capacity, and customer service for OTC products. The Director of PE&V also links upstream with R&D with respect to late-stage product/process development through commercial scale-up and launch phases. This individual drives and supports the identification and development of innovative solutions to problems and opportunities for continuous improvement of manufacturing process capabilities.

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations, the Companies' policies, procedures and guidelines, this position will establish project priorities in collaboration with leaders in Manufacturing, Operations, QA, and Compliance. The Director also assures clear customer and business benefits for approved projects. This individual will establish departmental resource strategy and plans to meet business requirements, and will influence the re-direction of projects and resources as indicated through collaboration with business partners. The Director PE&V will identify and approve goals and objectives for direct reports in alignment with McNeil company objectives and project prioritization. The Director will provide direction for and reviews the progress of approved projects and will provide guidance to resolve issues impacting timely completion and achievement of project goals.

The Director of PE&V will provide technical leadership and direction for the technology transfers into and the start-up of the Fort Washington OTC Liquids operation. This includes the scope of process development, process validation, interaction with Consent Decree commitments, and continued support of the commercial operation. This individual will manage the performance and development of direct reports including goal & objective setting, and career/succession planning. In collaboration with other functional leadership, this individual will establish policies and strategies for critical business processes such as site transfers, process and cleaning validation, and continuous process improvement. The Director will prepare and manage a departmental budget. The position will ensure quality and compliance in all actions by: attending GMP training on the schedule designated for the role and as appropriate for the role; adhering to strict compliance with procedures applicable to the role; exercising the highest level of integrity in the tasks performed; identifying, reporting, and seeking correction for deviations noted in the workplace in a timely and prompt manner. The Director of PE&V will embrace a behavior of employee involvement and commitment to doing the job right the first time and will ensure employees under the position's scope of responsibility are trained in required procedures for the execution of their role and maintain current with training requirements during the year. This individual will promote an environment of employee involvement in the workplace and will seek prompt identification, reporting and correction of deviations in the workplace as noted by employees.

Qualifications


A minimum of a Bachelor's Degree combined with a minimum of 15 years of relevant experience OR a Masters Degree combined with a minimum of 12 years of relevant experience OR a PhD combined with a minimum of 10 years of relevant experience is required. A focused degree in Chemistry, Pharmacy, Engineering or a closely related technical degree is required. It is required that this individual have relevant experience including product/process development of pharmaceutical/OTC products, manufacturing of pharmaceutical/OTC products; R&D, Technical Services and/or Engineering in the Pharmaceutical or OTC field. A minimum of 3 years of people management responsibilities is required.

An in depth knowledge and application of regulatory requirements and latest guidance in the development and manufacture of pharmaceutical and OTC products is required. Knowledge and application of pharmaceutical/OTC product and process development; life-cycle management of this class of products including strategies for continuous improvement is required. It is required to have knowledge and application of pharmaceutical/OTC manufacturing and formulation technologies for liquid and/or semi-solid dose manufacturing and product development. Previous experience preparing for Regulatory Inspections and Pre-Approval Inspection (PAI) is preferred. Six Sigma Green/Black Belt Certification is a plus.

This position is located in Ft. Washington, PA and may require up to 20% travel.

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Primary Location:North America-United States-Pennsylvania-Fort Washington
Organization: McNeil-PPC, Inc. (6101)