Commissioning and Qualification Engineer Downstream - LanceSoft Inc

Title: Commissioning and Qualification Engineer - Downstream
Location: Conshohocken PA/ Wilson, NC - 100% Onsite
Duration: 1 year

Pay Range: $110.00/HR - $126.00/HR

Summary:
Leading and coordinating the commissioning field team including CQ engineers, automation engineers, operator and site engineers, JSI sampling technicians, and external vendors and contractors.

**Candidate 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 transition to 100% onsite at the Wilson, NC site mid-year 2025

**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. . Must have a current passport.

Responsibilities:

• 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

Qualifications:

• BSc qualification (Engineering related discipline) is required.
• Must have at least 7 years of experience in a Drug Substance Biotech manufacturing environment.
• Must have at least 7 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 required.
• 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.
• Some travel required - 25% to PA location