BIM Standards & Compliance Lead - GMP
Merck & Co. Inc
Position Overview The Building Information Modeling (BIM) Services Administrator plays a crucial role in managing and optimizing the use of Computer Aided Design (CAD) and BIM technologies. This position is responsible for maintaining and managing central models, facilitating collaboration among stakeholders, and ensuring that all CAD and BIM processes align with organizational standards. This role works closely with project teams to streamline workflows, enhance data integrity, and support the successful execution of projects. Additionally, this role utilizes a proactive approach to problem‑solving in a fast‑paced environment while leveraging strong technical knowledge in CAD and BIM technologies from prior experience. Job Description What You'll Do Collaborates with IT to implement CAD and BIM systems, manages Autodesk license compliance and availability for users while ensuring timely updates and software availability for specific Autodesk products. Ensures BIM deliverables comply with Good Manufacturing Practice (GMP) documentation and validation requirements. Establishes clear audit trails for all model and data changes. Develops and maintains Client Information Requirements (CIR) with a GMP focus. Enforces compliance with site‑specific digital procedures. Audits supply chain BIM Execution Plans (BEPs) to confirm their ability and effectiveness to address critical systems. Oversees Common Data Environment (CDE) ensuring secure, validated, and access‑controlled information flows. Confirms metadata includes equipment identification, materials, cleaning validation requirements, and other regulated attributes. Acts as the client representative with design teams, contractors, and validation engineers. Assigns equipment tags, line numbers, and drawing numbers in accordance with standards. Reviews change control processes ensuring that any digital model or data change is reflected in GMP documentation. Organizes, develops, and maintains engineering and facility documentation and drawings. Provides CAD and BIM support to engineering, maintenance, and facility projects regarding the creation, revision, and handling of drawing and valve lists, line schedules, work orders, and other activities. Creates and revises BIM documentation for both GMP and non‑GMP requests. Trains CAD and BIM team members on core application skills and standards and BIMs serves users on procedures. Collaborates with other FUJIFILM sites to ensure alignment across the company, as needed. Performs other duties, as assigned. Minimum Requirements Bachelor's degree in engineering or related field with 5 years of experience in the AEC industry; or Associate's degree within a technical discipline or drafting and design with 7 years of experience in the AEC industry; or High School Diploma/GED with 9 years of experience in the AEC industry. 3+ years in a BIM coordinator, specialist or similar role. Experience with Revit, AutoCAD, and Navisworks for modeling, clash detection and coordination. Prior experience training or mentoring project teams on BIM workflows. Preferred Requirements Bachelor's degree in engineering. 5 years in a BIM coordinator or similar role. Prior client‑facing experience, including leading coordination meetings and delivering BIM‑related presentations. Working Conditions & Physical Requirements Ability to discern audible cues. Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. Ability to stand for prolonged periods of time, up to 30 minutes. Ability to sit for prolonged periods of time, up to 30 minutes. Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers. #J-18808-Ljbffr
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- ## GMP LeadApplylocations: Apex, NCtime type: Full timeposted on: Posted Todayjob requisition id: JR105112# **Title:**GMP Lead# **Job Description:****Job Overview**The GMP Lead will be responsible... ..., data collection* Logbook compliance-accurate completion* Task completion...Hourly payTemporary workImmediate startFlexible hoursShift work
- ...& Co. in Holly Springs, NC is seeking a Lead Tech of Instrumentation & Controls. This... ...managing daily I&C activities, ensuring compliance with FDA and cGMP regulations, and providing... ...adherence to safety and quality standards, with physical demands that include the...Shift work
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...CSL Seqirus is a leading global vaccine company, dedicated to advancing and protecting public health. We are seeking an experienced... ...maintains applicable regulatory systems to ensure tracking and compliance of deliverables. Applies CSL leadership capabilities....Local area3 days per week- A leading biopharmaceutical firm in Holly Springs, North Carolina seeks a Manufacturing Associate to lead production processing and ensure compliance with regulations. Candidates must have at least 4 years of experience in life sciences manufacturing, alongside a relevant...Night shift
- ...Merck & Co. is seeking a Senior Manufacturing Associate in Holly Springs, North Carolina. You will lead day-to-day operations on a 24/7 manufacturing floor, ensuring compliance with cGMP regulations. Join a high-growth team committed to bringing lifesaving therapies to...
- ...Position Overview The Lead Tech of Instrumentation & Controls is... ...across the site. The Lead ensures compliance with all applicable regulatory... ..., work instructions, and standard operation procedures (SOPs). Assist... ...Prior experience working in a GMP environment. Working...Night shift
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...& Qualification Manager to oversee capital projects, ensuring compliance and operational excellence. This role requires strong leadership... ...management skills, guiding teams through the C&Q lifecycle to support GMP operations. Candidates should have a Bachelor's degree in...Remote work- ...AEC, Pharmaceutical, or Life Sciences industries, and a Bachelor’s Degree in Engineering. The position involves ensuring design compliance and collaborating with various stakeholders throughout the project lifecycle. Some travel may be required. #J-18808-Ljbffr IPS-Integrated...BimWork at office
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Manufacturing Procurement Site Lead Join to apply for the... ...activities, while maintaining compliance with regulatory requirements,... ...regulatory requirements (e.g., GLP, GMP, ISO) and implement quality control... ...to‑date knowledge of industry standards and best practices, sharing...Remote workFlexible hours- ...Principal QMS Specialist in Holly Springs, North Carolina to lead the design and execution of the Quality Management System... ...) for our new facility. This role is pivotal in ensuring compliance with global standards while driving a culture of continuous improvement. Ideal...Relocation package
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A leading building materials supplier in Holly Springs, NC is seeking a Senior Weighmaster. This position requires overseeing scale systems to weigh materials, ensuring document accuracy, and maintaining records. Ideal candidates will have strong computer skills, attention...Hourly pay- ...Biotechnologies is seeking a Senior Manufacturing Associate in Holly Springs, North Carolina. You will lead operations on a 24/7 manufacturing floor, ensuring compliance with cGMP regulations while monitoring processes and coaching junior staff. Your contributions will...
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