Commissioning & Qualification Manager
The Newsome Group of Wilmington - Boston, MA

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The Commissioning and Qualification (C&Q) Manager is responsible for the implementation and governance of the Commissioning and Qualification program. This position will report to the Director, Engineering and will be a key contributor to the Facilities & Engineering team. The C&Q Manager will work closely with key stakeholders within the manufacturing sites to assure all design changes, commissioning needs, and operational support requirements are met. Excellent written and verbal presentation skills to support interactions with site management are required. Strong leadership skills to enable high performance teams in a rapidly changing business environment are required.

  • Primary C&Q interface with Project Management, Validation, and Quality.
  • Lead the implementation and use of the new site C&Q Program and ensure alignement with Corporate Standards along with engineering best practices on projects.
  • Responsible for project C&Q staff and contractor safety training and oversight.
  • Responsible for ensuring the overall quality of the engineering effort through execution of the site C&Q plan.
  • Lead development, approval, execution, resolution and reporting of all project specific engineering C&Q documentation
  • Responsible for project documentation management and quality of the Engineering Turnover Documentation.
  • Responsible for implementing project training program for site commissioning and qualification methods to execution team.
  • Responsible for managing commissioning and qualification phase advancement.
  • Monitor/evaluate contractor safety performance throughout the duration of the project.
  • Liaison between Engineering and Quality organization for Quality System Remediation gap assessments and commitments, deviations, change control assessment and implementation strategy.
  • Site SME for C&Q of automated systems. Site SME for Engineering C&Q methods.
  • Responsible for providing oversight to project contractors to ensure Site C&Q Program requirements are being utilized per procedures.
  • MUST HAVE prior Biotech or Pharmaceutical industry experience.
  • Requires a Bachelor’s Degree in Mechanical, Chemical or Electrical Engineering and 5+ years of Engineering Commissioning and Qualification experience.
  • Working knowledge of cGMPs, validation principles, sanitization and passivation, operation and certification, and Biopharmaceutical Manufacturing.
  • Must have demonstrated expertise in contemporary commissioning and qualification methods.
  • Must have demonstrated C&Q expertise in process automation, building automation systems and distributed control systems.
  • Must be able to establish strong working relationships with stakeholders (Quality, Manufacturing, and MTS ) to ensure high quality deliverables meeting cGMP and site quality requirements.
  • Must be able to facilitate practices consistent with the site C&Q program during the execution of the project scope through the execution manager and team.
Key Areas of Expertise:
  • Equipment & Automation Systems engineering
  • Current commissioning and qualification methods, including ISPE , ICH , and ASTM E2500 methodology
  • Knowledge of FDA and EU regulatory requirements pertaining to bio-processing facilities
  • Good Documentation Practice
  • Change control management
Qualified Candidates please email a Word or PDF resume to