Compliance Team, Inc.

Validation Project Manager

Job Locations US-MO-St. Louis
Posted Date 1 week ago(2/11/2018 4:47 PM)
ID
2018-1206
# of Openings
1
Category
Management

Overview

Compliance Team, Inc. is a leading provider of technical consulting services to our clients in the pharmaceutical, biotechnology, and medical device industries in the areas of commissioning, qualification, validation and regulatory compliance.  We are proud of our talented professionals and the major contributions they make to our clients’ successes on mission critical projects. 

 

 

Become part of our team. We have exciting opportunities for Validation Project Managers.  We seek top-notch professionals with project management experience to provide commissioning and validation services/reports for facility, process, utility systems and control systems in the bio-tech, pharmaceutical and/or medical device industry. 

 

Responsibilities

We have multiple validation projects beginning soon and require Validation Project Managers with various degrees of experience. The successful candidate will manage project(s) and personnel in the preparation and execution of commissioning and qualification protocols for plant equipment, facilities, and utilities for our clients.

Qualifications

• Bachelor degree in Engineering, Science, or Computer Science
• 15+ years of industry experience
• 5+ years as a Process Engineer and excellent, 3+ years Aseptic Manufacturing expertise
• 3+ years as a Project Manager in a PMO Office, supporting site-wide initiatives
• 2+ years in Validation Engineer and Quality Investigator type roles
• 2+ years defining and writing Capital Project requests
• Mid-to Senior level knowledge of Six Sigma and Lean Manufacturing practices
• Familiarity with commissioning and validation concepts, procedures, protocols and requirements
• Knowledge of FDA regulations and pharmaceutical and or medical device GMP's
• Familiarity with the pharmaceutical/medical device manufacturing process, facilities and equipment, calibration, and IQ, OQ, PQ requirements

 

The skills listed below are desired in the ideal candidate:

  • Exercises a high degree of initiative, judgment, discretion and decision making to integrate organizational priorities, meet deadlines, and achieve objectives.
  • Has a track record of managing projects to completion on time and within budget.
  • Strong ability to resolve problems, to prioritize solutions, to determine appropriate course of action, gain consensus on that recommendation, and to implement the decision.
  • Leadership skills to perform as a leader of cross-functional work teams.
  • Confidently interacts with peers, vendors, various personnel in scientific, engineering, QA, Validation, and operational disciplines.
  • Has excellent analytical and problem solving skills.
  • Detailed oriented, well-organized and ability to prioritize and meet deadlines
  • Excellent oral and written communication skills
  • Excellent organizational and time management skills
  • Strong decision making and creative problem solving skills
  • Ability to develop, organize, and manage multiple tasks

The successful candidate should demonstrate integrity, reliability, dedication, adaptability, innovation, and self-motivation.

 

 

 

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