Office Administrative and Customer Support - Facilities Project Coordinator

Office Administrative and Customer Support - Facilities Project Coordinator

• Administer the site CMMS as a power user: maintain asset hierarchy, equipment numbers, PM frequencies, job plans, spare parts lists, and equipment history in a validated state per 21 CFR Part 11 and

ISPE GAMP 5.

• Perform asset induction for new equipment: assign equipment numbers, build PM task sheets, establish parts lists, document equipment locations, and prepare equipment logbooks.
• Generate and distribute Equipment Parts List Reports, PM compliance reports, KPI dashboards, and reliability reports to support data-driven maintenance decisions.
• Author and revise Standard Operating Procedures (SOPs), Methods of Procedure (MOPs), PM task sheets, and work instructions for Facilities Department operations.
• Author and own Change Controls, CAPA reports, and audit findings related to facility, utility, and planning activities; close to commitment date.
• Review completed work orders, PM task sheets, and equipment logbooks for Good Documentation Practice (GDP), data integrity, and cGMP compliance prior to filing.
• Maintain all Facilities Department records in an audit-ready state and serve as planning and scheduling subject matter expert during regulatory inspections and internal audits.
• Manage facility and utility service agreements: track contract terms, write requisitions for renewals or new agreements, review service reports for performance against scope, and identify cost-saving opportunities.
• Generate Purchase Order Requisitions and track requisition status; coordinate with Finance to resolve invoicing and payment inquiries.
• Manage Engineering Service Request tracking and routing through completion.
• Schedule contractor work and escort contractors in GMP areas as needed; verify cGMP and site safety training prior to work; train contractors on facility documentation expectations (work orders, PM task sheets, equipment logbooks).
• Verify contractor deliverables for completeness, GDP compliance, and conformance to scope before sign-off.
• Serve as the Facilities Department training representative: maintain the training matrix, schedule required training, and run training compliance reports.
• Maintain the site security photo ID and access badge system for Facilities personnel and assigned contractors.
• Maintain a weekly emergency on-call response schedule and weekend contact list for the Facilities Department.
• Develop and present department metrics, dashboards, and improvement summaries (PM compliance, schedule attainment, backlog age, contractor variance, training compliance) to Facilities Management.
• Provide input on technician performance, training needs, and process improvement opportunities to the Facility Manager based on planning and documentation quality observed.
• Participate in safety observations, internal and external audits, and continuous improvement initiatives; address audit findings within commitment dates.
• Perform other related duties as required and/or assigned by the Facility Manager.

Minimum Qualifications (must have):

Experience/Requirements:

• Must have at least 6 - 8 years of related facilities planning, scheduling, maintenance coordination, or maintenance administration experience, including a minimum of 5 years in a GMP-regulated biotechnology, pharmaceutical, or life sciences manufacturing site.
• Must have demonstrated experience as a Computerized Maintenance Management System (CMMS) power user in a validated GMP environment (Blue Mountain RAM, Maximo, eMaint, SAP PM, or equivalent).
• Must have demonstrated experience independently authoring and closing GMP quality records including Change Controls, CAPAs, and audit responses.
• Must have demonstrated experience authoring Standard Operating Procedures (SOPs), Methods of Procedure (MOPs), and PM task sheets.
• Must have demonstrated experience managing service contracts, service agreements, and contractor coordination.
• Must have advanced proficiency in Microsoft Excel (including formulas, pivot tables, lookup functions, and conditional formatting), Microsoft Word, Microsoft PowerPoint, and Microsoft Visio.
• Must have working knowledge of FDA cGMP, ISO, and EH&S requirements in a manufacturing or laboratory environment.
• Must have strong oral and written communication skills for cross-functional coordination with Production, Quality, Engineering, EH&S, Finance, and external contractors.
• Must have demonstrated ability to manage multiple priorities and meet commitment dates in a fast-paced GMP environment.
• Must have the ability to work independently, in a group setting, with little direction, or with direct supervision.

Education:

• Minimum of an associate degree in a technical, engineering, business, facilities management, or related field; a bachelor's degree is preferred.
• Equivalent combination of high school diploma plus 10 or more years of directly related GMP facilities planning experience may be considered in lieu of degree.
• Preferred current OSHA 10-hour General Industry certification.
• Must hold a current and valid driver's license.

Preferred Qualifications:

• Bachelor's degree in engineering, facilities management, business administration, supply chain, or a related field.
• Documented advanced expertise with Blue Mountain RAM (Regulatory Asset Manager) as a CMMS power user or administrator.
• Experience applying maintenance planning and scheduling best practices per the SMRP Body of Knowledge.
• Experience developing and presenting reliability and maintenance KPI dashboards using Power BI, or equivalent.
• Experience with capital project scheduling, shutdown management, and outage planning in a life sciences environment.
• Familiarity with

FDA 21 CFR

Parts 210, 211, and 11;

ICH Q7, Q9, Q10

; and

ISPE GAMP 5.

• Familiarity with maintenance KPI standards (PM compliance, schedule attainment, wrench time, backlog age, mean time between failures, carryover).
• Ability to develop reliability reports to assist in identifying areas of concern that could develop into future problems.
• Soft skills: communication (oral and written), problem solving, demeanor, pace, influencing, leadership, and negotiating skills.
• Ability to work independently, in a group setting, with little direction, or with direct supervision.

This role is intended to be Contract to Perm. Shift differentials will be added for off shifts after conversion.

Rate is flexible for qualified candidates based on conversation.

EEO:

"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."