Document Control Lead Mace

• 3.

7 Indianapolis, IN Job Details Full-time 14 hours ago Qualifications Data integrity assurance Document control experience within pharmaceutical industry Primavera

FDA 21 CFR

Part 11 GMP Data quality management Construction document control SharePoint Primavera P6 Productivity software ProCore Pharmaceutical manufacturing facility experience Full Job Description At Mace, our purpose is to redefine the boundaries of ambition. We believe in creating places that are responsible, bringing transformative impact to our people, communities and societies across the globe. To learn more about our purpose, culture, and priorities, visit our strategy site. Within our consult business, we harness our unique combination of leading-edge practical expertise and project delivery consultancy to unlock the potential in every project.

Our Values:

Safety first

• Going home safe and well Client focus
• Deliver on our promise Integrity
• Always do the right thing Create opportunity
• For our people to excel

You'll Be Responsible For:

Define and document the end-to-end process for how documentation flows from EPCM contractors to the PMs at Mechanical Completion (MC), and on to either the CQ firms (PVP systems) or the TMP (non-PVP systems), prior to final turnover to Client Operations at TCCC. Identify and document the approved systems through which turnover documentation (design documents, CTOPs, VTOPs, and MC/TCCC approvals) is collected at each stage of the flow. Oversee the TMP's integration and use of Client's document and data systems (EIDA, Kneat, MCPlus, EPIC, Aconex, Procore, and Unifier), confirming each operates as the controlled system of record for its designated document set. Hold the TMP accountable for maintaining EPIC as the master repository for construction turnover documentation and Aconex for document control, correspondence, and transmittal management. Hold the TMP accountable for verifying CM

• and vendor-submitted turnover documentation (CTOPs, VTOPs, and addenda) for quality and completeness against contract and specification obligations.

Confirm the TMP defines and enforces entry and exit criteria for Mechanical Completion, Transfer of Care, PSSR, and TCCC, and maintains a Master Turnover Register as the controlled record of turnover and document status. Confirm the TMP delivers audit-ready turnover documentation, validates TOP completeness, PSSR completion, and punch list closeout ahead of Final TCCC transfer to Operations. Review the TMP's weekly and monthly turnover reports for accuracy and completeness, including RAG status, key risks, and decisions required, and monitor and report on TMP document control performance to program leadership.

You'll Need To Have:

Bachelor's degree in Engineering, Science, Information Management, or a related discipline. 10+ years of document control experience on large capital programs. Demonstrated experience with a formal DMS (Aconex, Veeva Vault, SharePoint with document control configuration, or equivalent). Experience in GMP pharmaceutical or biotechnology manufacturing capital projects. Deep understanding of GMP document control requirements (FDA 21 CFR Part 11, EU Annex 11 data integrity requirements). Experience managing contractor deliverable registers and document review cycles. Proficiency in Microsoft Office suite and document management platforms. Experince with Aconex or Veeva Vault specifically. Knowledge of Primavera P6 at a user level (for schedule interface). Mace is an inclusive employer and welcomes interest from a diverse range of candidates. Even if you feel you do not fulfil all of the criteria, please apply as you may still be the best candidate for this role or another role within our organization. We are also open to discussing part time, flexible, and hybrid working options if suitable within the role.