What are the responsibilities and job description for the Commissioning and Qualification Engineer – Upstream position at Infobahn Softworld Inc?
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.
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
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:
- 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.
- 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.
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
