Commissioning and Qualification Engineer

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.