Commissioning and Qualification Engineer Downstream
4 days ago
Description:
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 remote 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
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
Hours per Day
8
Hours per Week
40
Total Hours
2,096.00
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