Engineer 4 in

Title: Commissioning and Qualification Engineer – Downstream Location: Should be local to Wilson, NC or nearby. For the first 6 months of the role, it will be 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 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 avoids mutually exclusive activities are avoided. o Lead and supervise 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 of leveraging o Reviewing commissioning test documents prior to 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, RAMS are in place for area commissioning activities. o 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. o 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. Essential: 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

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