Commissioning and Qualification Engineer – Upstream

Title: - Commissioning and Qualification Engineer – Upstream

Location: Wilson, NC 27893

Duration: 12 months (with possible extensions)

Job Description

Title: Commissioning and Qualification Engineer – Upstream

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 Preferred Qualifications:
  
  

Essential

• 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.
  
  

Education Required

Bachelor’s degree is required, in Engineering

Special Credentials / Certifications Required

Must have C and Q start up experience of Large Molecule 10-15k bioreactor plant

Total Working Experience

10 years C and Q

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