Commissioning and Qualification Engineer – Upstream

1 week ago

wilson, United States eTeam Full time

Title: Commissioning and Qualification Engineer – Upstream

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


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.

o Ensures equipment usage is coordinated to support schedule development and mutually exclusive activities are avoided.

o Led and supervised 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 to leveraging

o Reviewing commissioning test documents before 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, and RAMS are in place for area commissioning activities.

o Adhere to and monitor the schedule and timeframes milestones within the schedule. Work with the CQV scheduler to prepare and communicate 4-week lookahead plans and micro-schedules as required.

o Manage and close out exceptions during static and dynamic commissioning Preferred Qualifications:


Essential:

• BSc qualification (Engineering related discipline).

• At least 10 years’ experience in a Drug Substance Biotech manufacturing environment.

• At least 10-15 years of 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 with 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, and 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.


Education Required:

Bachelor’s degree is required, in Engineering


Special Credentials / Certifications Required:

Must have C and Q start-up experience of Large Molecule 10-15k bioreactor plant


Total working Experience:

10+ years C and Q


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

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