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.