Offer summary

Qualifications:

Bachelor's degree in Engineering required, 10+ years of C and Q start up experience, 7+ years in a Drug Substance Biotech environment, Proven track record in a cGMP regulated environment.

Key responsabilities:

Lead commissioning field team coordination

Manage exceptions during commissioning and reporting

Job description

Job Description:

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

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

Experience:

Must have at least 10+ years of C and Q start up experience of Large Molecule 10-15k bioreactor plant
At least 7+ years’ experience in a Drug Substance Biotech manufacturing environment.
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.
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

Will travel to Ireland up to possibly 1 time in the first 6 months for training, that can be 1-2 weeks long in duration. Travel will be reimbursed/covered. Must have a current passport.

Skills:

This role requires experience and knowledge as Commissioning & Qualification Engineer
Must know Delta V
Must have 10 years of experience

Education:

Bachelor’s degree is required, in Engineering

About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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