Qureos Mentor

BioPharma Consulting JAD Group

<div>Perform one or more of the following duties and responsibilities in support Quality Assurance program under minimal supervision.
FUNCTIONS<ul><li>
Review and approve product MPs.</li><li>
Approve process validation protocols and reports for manufacturing processes.</li><li>
Request Quality on incident triage team.</li><li>
Approve Environmental Characterization reports.</li><li>
Release of sanitary utility systems.</li><li>
Approve planned incidents.</li><li>
Represent QA on NPI team.</li><li>
Lead investigations.</li><li>
Lead site audits.</li><li>
Own site quality program procedures.</li><li>
Designee for QA manager on local CCRB.</li><li>
Review Risk Assessments.</li><li>
Support Automation activities.</li><li>
Support facilities and environmental programs.</li><li>
Review and approve Work Orders.</li><li>
Review and approve EMS/BMS alarms.</li><li>
Approve NC investigations and CAPA records.</li><li>
Approve change controls.</li><li>
Provide lot disposition and authorize lots for shipment.</li></ul>
COMPETENCIES/SKILLS<ul><li>
Project management skills.</li><li>
Strong organizational skills, including ability to follow assignments through to completion.</li><li>
Initiate and lead cross functional teams.</li><li>
Enhanced skills in leading, influencing and negotiating.</li><li>
Strong knowledge in area of expertise.</li><li>
Collaborate and coordinate with higher level outside resources.</li><li>
Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development.</li><li>
Demonstrate ability to interact with regulatory agencies.</li><li>
Strong word processing, presentation, database and spreadsheet application skills.</li><li>
Strong communication (both written and oral), facilitation and presentation skills.</li><li>
Strong skill in working independently and to effectively interact with various levels.</li><li>
Advanced data trending and evaluation.</li><li>
Ability to evaluate compliance issues.</li></ul> 
Requirements 
EDUCATION<ul><li>
Doctorate OR</li><li>
Masters + 2 years of experience in Quality Systems (Deviations, CAPAs, Change Controls) and Equipment, Processes and Facilities Validation. OR</li><li>
Bachelors + 4 years of experience in Quality Systems (Deviations, CAPAs, Change Controls) and Equipment, Processes and Facilities Validation. OR</li><li>
Associates + 8 years of experience in Quality Systems (Deviations, CAPAs, Change Controls) and Equipment, Processes and Facilities Validation. OR</li><li>
High school/GED + 10 years of experience in Quality Systems (Deviations, CAPAs, Change Controls) and Equipment, Processes and Facilities Validation.</li></ul>
Preferred Qualifications:<ul><li>
Quality Professional with experience in Quality System and Validations.</li><li>
Knowledge or to be familiar with in PASx/MES application, MAXIMO, SAP, LIMS, QMTS and Veeva.
</li>Available during weekends and holidays as requested, always available to be on site. 
<li>
</li></ul> 
 
Benefits 
<ul><li>
 Administrative Shift</li><li>
1-year contract</li></ul></div>

Specialist QA

<div>The Senior Engineer independently leads and/or directs process optimization, troubleshooting, and engineering project execution within manufacturing, operations, pilot plant, or capital project environments.
This role applies advanced engineering principles to design, implement, and optimize complex systems, processes, and facility modifications. The engineer is responsible for developing, analyzing, and presenting data-driven solutions for issues and projects of significant scope and complexity, while serving as a technical subject matter expert in at least one engineering discipline.
Key Responsibilities<ul><li>
Lead complex and novel assignments requiring development of new or improved engineering techniques and procedures.
</li><li>Develop and implement engineering policies and procedures impacting multiple functional areas.
</li><li>Supervise, coordinate, and review the work of engineers, associates, and technicians.
</li><li>Apply advanced and cross-disciplinary engineering principles to solve complex problems.
</li><li>Serve as a recognized subject matter expert (SME) in a specialized technical area.
</li><li>Plan and execute engineering projects using sound technical judgment and methodologies.
</li><li>Lead characterization studies and process optimization initiatives.
</li><li>Troubleshoot operational issues in manufacturing, pilot plant, and production environments.
</li><li>Develop innovative solutions using data analysis, engineering theory, and experimentation.
</li><li>Interpret and present complex technical data to support decision-making.
</li><li>Develop technical solutions for complex system and facility challenges requiring creativity and ingenuity.
</li><li>Collaborate with cross-functional teams (Manufacturing, Process Development, Quality, Validation, Facilities, Utilities).
</li><li>Define requirements and provide recommendations for large-scale system or facility modifications.
</li><li>Support execution of capital projects within scope, schedule, budget, and quality constraints.
</li><li>Coordinate external consultants, contractors, architects, and engineering firms.
</li><li>Develop and manage project budgets across multiple disciplines.
</li><li>Support and ensure compliance with validation processes (IQ/OQ/PQ).
</li><li>Contribute to validation protocol development and execution.
</li><li>Ensure adherence to GMP, GLP, and regulatory requirements.
</li><li>Maintain and review technical documentation in a regulated environment.
</li><li>Lead cross-functional teams and engineering initiatives.
</li><li>Manage multiple projects simultaneously, ensuring timely delivery.
</li><li>Delegate tasks and oversee execution of project deliverables.
</li><li>Manage contractors, vendors, and external resources.
</li><li>Support financial planning, cost estimation, and project tracking.
</li></ul>Required Skills<ul><li>
Strong knowledge of pharmaceutical/biotech manufacturing processes.
</li><li>Working knowledge of validation lifecycle (IQ/OQ/PQ).
</li><li>Familiarity with GMP/GLP regulations and documentation practices.
</li><li>Advanced problem-solving and analytical engineering skills.
</li><li>Ability to apply engineering principles to production environments.
</li><li>Strong technical writing, reporting, and presentation skills.
</li><li>Effective verbal communication and cross-functional collaboration.
</li><li>Ability to manage multiple projects and priorities simultaneously.
</li>Proficiency in standard computer and engineering tools. 
<li>
</li></ul> 
 
Requirements 
<ul><li>
Doctorate degree, OR
</li></ul><ul><li>Master&rsquo;s degree + 2 years of Engineering experience, OR
</li><li>Bachelor&rsquo;s degree in Engineering + 4 years of Engineering experience
</li></ul>Preferred Qualifications<ul><li>
Degree in Mechanical or Chemical Engineering.
</li><li>Experience in aseptic manufacturing environments.
</li><li>Hands-on experience with Fill/Finish operations (vial and syringe filling lines).
</li><li>Experience supporting:
</li><li><ul><li>Process characterization studies
</li><li>Performance Qualification (PQ) activities
</li><li>New Product Introductions (NPI)
</li></ul></li><li>Strong experience in capital projects, system design, and equipment installation.
</li><li>Demonstrated ability to lead complex engineering projects in regulated environments.
</li>Experience coordinating contractors, vendors, and multidisciplinary teams. 
<li>
</li></ul> 
 
Benefits 
<ul><li>
Administrative Shift &amp; Non-Standard Shift (night shift and/or 12 hours shifts)
</li><li>8-month contract</li></ul></div>

Senior Engineer

Join BioPharma Consulting JAD Group and explore 2   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

BioPharma Consulting JAD Group

About Company

Specialist QA

Senior Engineer