Commissioning and Qualification Engineer

1 week ago

wilson, United States Source One Technical Solutions Full time

Source One is a consulting services company and we’re currently looking for the following individual to work as a consultant with our direct client, a global pharmaceutical manufacturer in Wilson, NC. This role will require you to be onsite.


Title: Commissioning and Qualification Engineer – Downstream/Upstream

Openings: 2

w2 hourly: up to $125.00 per hour

Duration: 12 months, with likely extension


***Location: Should be local to Wilson, NC or nearby. For the first 6 months of the role, it will be remote supporting sites in PA. The role will officially move to the Wilson, NC site mid-year 2025.


Responsibilities:

Leading and coordinating the commissioning field team including CQ engineers, automation engineers, operator and site engineers, JSI sampling technicians, and external vendors and contractors.


  • Ensures equipment usage is coordinated to support schedule development and avoids mutually exclusive activities are avoided.
  • Lead and supervise a team of Piping/Mechanical, Electrical and Instrumentation technicians to support commissioning activities
  • Coordinating the interfaces of commissioning execution (Construction Management Contractor, Utilities, Qualification, Automation, Instrumentation, Electrical, etc.)
  • Lead daily coordination meetings to fine-tune the commissioning execution with all involved parties
  • Tracking and reporting of commissioning progress
  • Tracking of deficiencies, including planning and executing the remediation actions
  • Ensuring compliance of the commissioning activities with qualification requirements where test results are subject of leveraging
  • Reviewing commissioning test documents prior to client approval
  • Technical SME – provide mentorship for team members in supporting issue resolution and consistency in approach across the team.
  • Co-ordinates the management of change
  • Ensuring full compliance with safety procedures and ensuring permits, SPA, RAMS are in place for area commissioning activities.
  • Adhere to and monitor the schedule and timeframes milestones within the schedule. Work with CQV scheduler to prepare and communicate 4 week lookahead plans and micro-schedules as required.
  • Manage and close out of exceptions during static and dynamic commissioning


Essential: Must Have

  • Special Credentials / Certifications Required:Must have C and Q start up experience of Large Molecule Downstream processes
  • Total working Experience: 10+ years C and Q
  • Education Required: Bachelor’s degree is required, in Engineering
  • Travel:- Will travel to Ireland up to possibly 3 times in the first 6 months for training, that can be 1-2 weeks long in duration. Travel will be reimbursed/covered.
  • Will also need to be able to travel to PA 25% of the time in the first 6 months of the position


Preferred Qualifications:

  • BSc qualification (Engineering related discipline).
  • At least 10 years’ experience in a Drug Substance Biotech manufacturing environment.
  • At least 10-15 years C and Q experience and a proven track record within a cGMP regulated environment.
  • At least one major Biotech project as a C and Q Lead.
  • Planning and organizing skills.
  • Excellent interpersonal and influencing skills
  • Excellent written and oral communication skills.


Desirable:

  • Experience of Digital C and Q systems.
  • Strong knowledge of Commissioning and Qualification Regulations and Standards.
  • Ability to work under pressure and meet deadlines.
  • Ability to work in a team, coordinate colleagues, contractors and consultants.
  • Strong initiative and the ability to proactively identify required tasks.
  • An organized approach to working, task prioritization and time management.

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