Engineering Documentation Control Lead in Wilson, NC

Notes:

Should source out of NC, where candidates can commute to Wilson, NC to be onsite

The role will be for the 1st 6 months, supporting sites in PA

Must be able to travel to PA sites once a month during the first 6 months

Will be required to do some international travel, to Ireland up to 1 trip in the first 6 months for training (trip could last 1-2 weeks)

Should have a valid/active passport

Then the role will move to Wilson, NC and will be 100% onsite

• This role requires experience as Engineer Document Control Lead
• Must have at least 7 years of exp
• Exp with large capital projects
• Document control exp
• Exp with engineering drawings/instructions
• Knowledge of construction interface
• Exp with technical document review

Title: Engineering Documentation Control Lead

Duties and Responsibilities

• Define and develop an electronic EDC process, such that all documents and drawings handover over are digital only (i.e. no paper) and the process is in alignment with enterprise electronic document standards.
• Ensure correct definition of Supplier Documentation Index (SDI) for all Vendor and Trade packages.
• Coordinate review and approval of drawings and documents (e.g. Engineering, C and Q, Maintenance, Automation).
• Ensure all signoffs of turnover packs in a timely manner, as per project schedule requirements.
• Expedite closure of all queries and comments from document reviews.
• Adhere to project schedule targets, particularly those associated with the handover of documentation at both Mechanical Completion (Green Tag) and Commissioning and Qualification (Blue Tag) phases.
• Ensure documents are uploaded as they become available, in a progressive manner, to level load the review and approval process and prevent bottle necks.
• Track progress using KPIs, e.g. document submissions from vendors, % complete of each VTOP/TTOP, review and approval status, due dates for completion, etc.
• Manage an Issue Resolution tracker, to track all potential issues, delays, etc.
• Adequately resource document TTOP review process, to allow for peaks and troughs, to ensure no backup of progress.
• Audit VTOP/TTOP content quality throughout the process, to ensure alignment with expected standards.
• Ensure as-built P and IDs for all elements of project. (In Smart format and in Non-Smart CAD - AutoCAD 2019 is the current set-up format, with associated layers.)

Preferred Qualifications:

Essential

• BSc or Diploma qualification (Engineering related discipline).
• At least 10 years EDC experience and a proven track record within a cGMP regulated environment.
• At least one major GMP manufacturing plant capital project as an EDC Lead.

Special Credentials / Certifications Required:

• Must have Engineering Documentation Control experience in a pharmaceutical start up situation

Education Required:

• Bachelor’s degree is preferred, Diploma will suffice; in Engineering, Business, Operations, etc.

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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