Engineering Manager-III

ID# DCPA30148

dinaliC is an international consulting firm specialized in projects for numerous industries. We are dedicated to provide contract and permanent opportunities for skilled professionals in their area or areas of expertise.

The individual will be expected to lead and manage the validation program while simultaneously balancing business, technical and quality issues and enhancing the site master validation plan. 

As required, the individual will provide support to change control functions by reviewing and approving change controls related to validation. 

Leadership

  • Develop and manage multi-functional validation and qualification Master Plans and plant-wide Master Validation Programs. 
  • Consulted extensively by associates with high degree of reliance placed on the advice, decisions, guidance, interpretations and recommendations made. 
  • Initiate and maintain extensive contacts with key representative of McNeil and other organizations and companies both inside and outside the McNeil family of companies. 
  • Mentor Process Validation Engineers, Specialists and the Change Control Coordinator as required. 

Compliance Focus 

  • Signatory authority on official validation documents 
  • Review and approve cleaning, computer, packaging, process and system, equipment, facility and utility qualifications (IOPQs), change controls and standard operating procedures. 
  • Author and maintain Master plans as required. 
  • Initiate and maintain extensive contact with Plant Engineering, Information management, Laboratories, Operations, Project Management, Quality, R&D, etc. as a Validation Subject Matter Expert in order to ensure that concepts, designs, specifications, implementation and maintenance of new existing GXP regulated systems follow standard operating procedures, industry standards and practices. 
  • Apply intensive and diversified knowledge of engineering principles and practices to validation and related fields for the purpose of interpreting, organizing and coordinating validation activities. 
  • Demonstrate creativity, foresight and mature judgment in anticipating and solving unprecedented validation issues, determining program objectives and requirements, organizing and coordinating validation activities as required. 
  • Plan and conduct research in problem areas of considerable scope, complexity and of limited definition utilizing unconventional or novel approaches, sophisticated research techniques or a series of conceptually related studies. 

Information Transfer 

  • Communicate and train local personnel on corporate policies and guidelines, validation expectations, regulatory and compliance trends, and new engineering/validation concepts and developments. 
  • Keep abreast of new engineering, scientific and validation practices/regulations affecting the organization. 
  • Prepare and publish reports (APRs) related to projects and functional areas. 
  • Maintain, track and communicate metrics to contain emerging adverse trends and develop future planning activities 

 

 



Knowledge, Skills and Abilities: 

  • Bachelors degree in Biology, Chemistry, Microbiology, Engineering or related technical degree. 
  • 8-10+ years experience in a GMP-related industry. 
  • Experience in writing and executing validation documents. 
  • Working knowledge of change control activities. 
  • Excellent working knowledge of cGMPs 
  • Strong technical, interpersonal, communication and facilitation skills. 
  • Good understanding of engineering, computer and pharmaceutical manufacturing systems. 
  • Knowledgeable of cGMPs and industry standards for equipment, process, packaging and cleaning validations. 

Position Details:

Pharmaceutical

Engineering

Start Date: 
2-17-2014

Lancaster`, PA

Full Time

DCPA30148

No

No