Pinnaql ยท 2 days ago
TOP Reviewer - Engineering Documentation Control Specialist
Pinnaql is a trusted consulting partner to regulated life sciences companies, providing deep technical, validation, and quality expertise. The TOP Reviewer will be responsible for managing documentation related to engineering, procurement, and construction activities, ensuring compliance with project specifications and regulatory requirements.
Biotechnology
Responsibilities
Manage the receipt, review, and distribution of vendor and trade package documentation related to engineering, procurement, and construction activities
Track and monitor the progress of documentation deliverables to ensure timely completion
Review turn-over packages for completeness, accuracy, correct revisions, and adherence to project standards and specifications
Collaborate with vendors, trades, and internal project teams to resolve documentation discrepancies and close outstanding items
Maintain organized digital and physical document repositories, ensuring proper version control and document integrity
Prepare and generate reports on documentation status, outstanding items, and turnover readiness
Support audit and quality review processes by providing required documentation and coordination
Assist in the preparation and finalization of turn-over packages for project handover
Follow established documentation control procedures and contribute to continuous improvement initiatives
Qualification
Required
Proven experience in document control, engineering administration, or a related role supporting large engineering, construction, or manufacturing projects
Strong knowledge of document management systems and document control best practices
Proficiency with electronic document control tools (e.g., SharePoint, Aconex, Documentum, or equivalent)
Excellent organizational skills with strong attention to detail
Ability to work independently and collaboratively within multidisciplinary teams
Effective communication skills to liaise with vendors, trades, and internal stakeholders
Bachelor's degree in Engineering, Construction Management, or a related field
Experience supporting pharmaceutical, biotech, medical device, or other regulated industry projects
Familiarity with regulatory frameworks such as FDA, EMA, or comparable standards
Previous experience in document control, engineering administration, or a related role on large-scale projects
Familiarity with turn-over processes for packaged equipment, trade contractors, or vendor documentation
Experience working in construction, manufacturing, or engineering environments, preferably within regulated industries such as life sciences, pharma, or biotech
Strong understanding of engineering documentation, including drawings, instrument specifications, and vendor technical packages
Experience with digital document management systems and workflows (e.g., Autodesk, PIMS)
Knowledge of Quality Assurance (QA) and Quality Control (QC) principles as they relate to documentation management
Skills in data management, document tracking, and status reporting
High attention to detail and accuracy when reviewing technical documentation
Ability to follow established documentation control procedures and protocols
Strong organizational, tracking, and communication capabilities
3+ years of experience in a similar role
Company
Pinnaql
At Pinnaql we believe that different perspectives and backgrounds are what make a company flourish.
H1B Sponsorship
Pinnaql has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
Funding
Current Stage
Early StageRecent News
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