Title: Engineer Documentation Control Lead

Location: Wilson, NC - 100% Onsite

Duration: 1 year

Summary:

The EDC lead will 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.

**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 1 time in the first 6 months for training, that can be 1-2 weeks long in duration. Must have a current passport.

Responsibilities:

• 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.)
• Incorporate all intervening site changes to any existing P&IDs, including all x-ref changes.
• Ensure redraft of all Vendor P and IDs to format.
• Ensure all project A/E and Vendor drawings are handed over in the correct format.
• Ensure all turnover packs, drawings and P and IDs are correctly and accurately uploaded to Meridian.

Qualifications:

• Bachelor’s degree is preferred, BSc or Diploma qualification (Engineering related discipline). Diploma will suffice, in Engineering, Business, Operations, etc.
• At least 7+ years of EDC experience and a proven track record within a cGMP regulated environment.
• Must have Engineering Documentation Control experience in a pharmaceutical start up situation
• At least one major GMP manufacturing plant capital project as an EDC Lead.
• Planning and organizing skills.
• Excellent interpersonal and influencing skills.
• Excellent written and oral communication skills.
• Experience of Digital EDC systems.
• Strong knowledge of EDC processes and procedures.
• 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