Work closely with Project Leads, Site Engineering, Process Engineering, Automation Engineering, Facilities / Maintenance and Metrology, Project Document Control
Ensure all engineering documentation is compliant with Spark standards, regulatory requirements, and internal guidelines.
Participate in project meetings to understand project scope, milestones, and deliverables.
Coordinate the review, approval, and change management processes for all project-related documents with cross functional departments.
As necessary develop templates, standards and workflows for future documentation to ensure consistency and efficiency.
Provide input on document design and layout to align with the Electronic Engineering System requirements.
Utilize Electronic Engineering document management systems to track and manage revisions and approvals.
Coordinate and support technical data migration from Project SharePoint into the electronic engineering documentation management system.
Setup and manage workflows for engineering documentation and records needing to be reviewed and approved in the electronic engineering documentation management system. (ETOPS, CTOPS, VTOPS, Engineering Drawings, Commissioning Documentation, Standards, Procedures, Records, Plans etc... )
Setup and manage workflows for engineering model (Revit) to be received managed and maintained in Meridian.
Maintain Meridian system for the GTIC Project and drawing changes.
Maintain existing drawing standards and plotting styles for future work
Manage EDMS workflows as ERG administrator.
Verify Drawings / Documents match Spark Standards.
Develop drawing procedures and tracking mechanisms as required (EDMS - electronic data management system)
Maintain, Communicate to Project teams and A/E firms approved engineering standards and procedures.
Determine List of Approvers and workflows for all documents / drawings / records / projects - SMEs, Building Owners, End Users, Validation, QA, EH&S, Security, Corporate Facilities
Communicate drawing lists, track status, update and circulate
Create, maintain, and communicate Revit Block Libraries with standard symbology and legends
Maintain and communicate CAD Title Blocks
Manage Engineering Record Group (ERG) CAD, drawing, document, and model Program - Procedures, tracking mechanisms (EDMS) / Sharepoint,
Develop and maintain Meridian structure, uploads, and notifications
Maintain Meridian system for GTIC project and associated drawing changes.
Update Spark drawings with as-builts received from A/E firms and subcontractors and track changes
Work with engineering team and subcontractors to maintain naming conventions for drawings and models
Receive drawings, drawing sets, turnover packages from the GTIC project and migrate to Meridian
Prepare meeting agendas and minutes
Provide Training to Spark and Project personnel required to interact and utilize Meridian.
Education and Experience Requirements
Include educational requirements or equivalency, required years and type(s) or experience, and necessary licenses or certificates.
Bachelor's degree in Technical field, English, Communications, or a related field.
Proven experience (5+ years) in documentation management and Electronic Engineering systems such as meridian and Autodesk, preferably in the cGMP Pharmaceutical or equivalent biotechnology industry.
Familiarity with Autodesk applications (Cad / Revit), as well as Electronic Documentation managements systems (Meridian)
Strong ability to explain complex information in a clear and concise manner.
Excellent written and verbal communication skills.
Proficiency in MS Office and documentation tools such as Adobe Acrobat, Blue Beam, Visio, and DITA XML.
Experience with project management and collaboration tools.
Ability to work independently and manage documentation / record workflows with tight deadlines.
Development / lifecycle maintenance of technical Engineering documentation, SOP's, records, standards, and spec's.
Key Skills, Abilities, and Competencies
Describe critical skill and abilities needed to successfully perform the job, which should be representative of the knowledge, skills, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Knowledge of pharmaceutical manufacturing processes and equipment.
Experience in capital projects within pharmaceutical or biotechnology settings.
Proven track record in a CAPEX program environment.
Strong ability to manage time and balance multiple priorities.
Proven cross-functional collaborator with Excellent oral and written communication skills.
Highly motivated and detail oriented
Compensation:
$40-60/hr
Exact compensation may vary based on several factors, including skills, experience, and education.
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.