What are the responsibilities and job description for the Commissioning and Qualification Engineer - Downstream position at LanceSoft?
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.
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