Engineering Documentation Control Lead

Title: - Engineering Documentation Control Lead

Location: Wilson, NC 27893

Duration: 12 months (with possible extensions)

Job Description

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.)
• 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.
  
  

Preferred Qualifications

• 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.
• Planning and organizing skills.
• Excellent interpersonal and influencing skills.
• Excellent written and oral communication skills.
  
  

Desirable

• 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.
  
  

Special Credentials / Certifications Required

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

Total Working Experience

10+ years EDC

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