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