Title: Commissioning and Qualification Engineer – Upstream
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
- NC work location: 5100 Corporate Parkway, Wilson, NC 27893
Job Description:
Leading and coordinating the commissioning field team including CQ engineers, automation engineers, operator and site engineers, JSI sampling technicians, and external vendors and contractors.
o Ensures equipment usage is coordinated to support schedule development and mutually exclusive activities are avoided.
o Led and supervised a team of Piping/Mechanical, Electrical and Instrumentation technicians to support commissioning activities
o Coordinating the interfaces of commissioning execution (Construction Management Contractor, Utilities, Qualification, Automation, Instrumentation, Electrical, etc.)
o Lead daily coordination meetings to fine-tune the commissioning execution with all involved parties
o Tracking and reporting of commissioning progress
o Tracking of deficiencies, including planning and executing the remediation actions
o Ensuring compliance of the commissioning activities with qualification requirements where test results are subject to leveraging
o Reviewing commissioning test documents before client approval
o Technical SME – provide mentorship for team members in supporting issue resolution and consistency in approach across the team.
o Co-ordinates the management of change
o Ensuring full compliance with safety procedures and ensuring permits, SPA, and RAMS are in place for area commissioning activities.
o Adhere to and monitor the schedule and timeframes milestones within the schedule. Work with the CQV scheduler to prepare and communicate 4-week lookahead plans and micro-schedules as required.
o Manage and close out 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 of 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 with 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, and 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
