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Senior Project Manager

4 months ago

Cary, United States Compli Full time
Job DescriptionJob Description

Senior Project Manager – Commissioning, Qualification and Validation

COMPI is a full-service engineering contracting and consulting services company with a life sciences division specializing in pharma, biotech, API, Medical Device and laboratory facilities. We are seeking an experienced Senior Validation Engineer to join our growing team. COMPI differentiates itself through an integrated approach to engineering, construction commissioning and validation.

Responsibilities:

  • Able to manage (schedule, budget, resources) and execute multiple projects to meet client’s priorities

  • Client retention and growth of revenue from existing clients

  • Prepare and execute commissioning / validation lifecycle documents

  • Participate in any stage of clinical or commercial production including green field construction, facility renovation, new product development, product launch, or product/process upgrade

  • Proficient in current Good Manufacturing Practices and other applicable regulations

  • Write summary reports for validation and qualification protocols

  • Support project milestones, priorities and deadlines

  • Write operating procedures for technical equipment and practices and procedures

  • Perform system and process risk assessments and analyses

  • Schedule and coordinate protocol execution with other departments including manufacturing, facilities and project management

  • Develop project specific validation plans and strategy

  • Able to manage and execute multiple projects to meet client’s priorities

  • Provide a practical approach to problem solving

  • Individuals must represent COMPI at client sites and interact confidently with clients, contractors, management and peers

Requirements:

  • Bachelor’s degree in a related life sciences or requisite industry training and experience

  • Ability to work independently or in collaboration with others

  • In depth understanding and application of validation principles, concepts, practices and standards

  • Proficient in current Good Manufacturing Practices and other applicable regulations

  • Experienced with all pertinent industry best practices (e.g., ISPE) including development and execution of all applicable system life cycle deliverables (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report

  • Demonstrated expertise in at least one aspect of system qualification and regulatory compliance (e.g., EMEA, GCP, GLP, GMP, QSR) and internal requirements employing regulatory guidance and industry standards

  • Ability to manage a project team (budget, schedule, and resources)

  • Excellent written communication skills with emphasis in technical writing

  • Proficient in Microsoft Word, Excel, Power Point and Projects

All candidates must be legally eligible to work in the United States.

Just be willing to travel regionally and / or nationally throughout the U.S.

We are an equal opportunity employer M/F/D/V

COMPI does not accept unsolicited resumes from recruiters / third parties.