Posting ID: JP-002228105
Hi everyone! Please see below for a great opportunity as a Process Engineer/Scientist in Burlington, MA:
• Process Engineering IIs / Process Scientists are expected to provide technical, quality and compliance leadership and mentorship of less experienced personnel within the department.
• Tech transfer client product/process information with the goal of designing a manufacturing process to support GMP production of the client product.
• Identify and specify process equipment and single use components needed for client tech transfer.
• Co-lead and lead process development activities including process characterization at lab, pilot and full scale developing techniques and process parameters specific to the client’s product while maintaining critical product attributes.
• Perform lab and pilot processing operations (ENG and GMP) including equipment preparation, bulk product formulation, sterile filtration, and filling to facilitate process development and internal technology transfer.
• Develop Engineering and GMP batch records for client-specific formulation and filling / finish operations.
• Author instructions for the operation of equipment and process flows into the clean room facility.
• Align with agreed upon client Scope of Work proposals containing standard statistical approaches (JMP software) for on-time report milestone delivery.
• Lead the technical interface with the client via regular attendance at meetings with presentations and reports.
• Participate in regularly scheduled project team meeting providing routine project updates identifying actions, prioritizations, risks and project needs.
• Operate as an SME and author/investigator for GMP investigations; e.g., CAPA, deviations, and change requests. This includes closure reports for investigations that include Root Cause Analysis and CAPA planning / effectiveness actions as assigned to Process Engineering.
• Operate and work within the Process Engineering Laboratory in a safe and compliant manner. Maintain equipment in clean, organized and well maintained state.
• Adhere to site safety requirements and maintain an overall safety culture.
• Understand and follow OSHA, HAZOP, and company procedures and guidelines when handling or disposing of hazardous materials.
• Maintaining full compliance to defined department training requirements.
• Will open Deviations and author/complete required procedural and Change Controls / CAPAs in process to the attention of the shift supervisor, Engineering Manager, and/or Quality Assurance to ensure timely quality system completion and closures and communication.
tech transfer, technology transfer, filitration, CAPA, root cause analysis, lyophilization
Top Skills Details:
tech transfer,technology transfer,filitration,CAPA,root cause analysis,lyophilization
Additional Skills & Qualifications:
• Bachelors of Science degree in Scientific, Engineering, or related field required
• 3+ years’ experience in a cGMP/FDA regulated environment
• Advanced degree in related field may be considered in lieu of experience
• Qualification in aseptic technique and familiarity with clean room personnel/equipment flows is desirable.
• Knowledge of process flows; e.g., disposables strategies, filtration, mixing strategies, fluid transfer to and from various vessels/biobags.
• Working knowledge of engineering processing aids such as sanitary connections, valves and pharmaceutical equipment and process design.
• Computer literate with excellent working knowledge of spreadsheet software. Working knowledge of Visio or equivalent drawing programs a plus.
• Experience with particle size reduction techniques, such as extrusion, microfluidization, or homogenization.
• Experience with lyophilization processes and principles are also desirable.
• Knowledge and understanding of the principles associated with aseptic filling technology (e.g. rotary piston/positive displacement pump, peristaltic pump systems).
• Familiarity and understanding of cGMP’s in a accordance with 21CFR210, and 21CFR211.
• Experience leading and working in a fast-paced environment and success in cross-collaborative team dynamic.
• Experience with CIP/SIP a plus.
• Experience in executing the concepts within Quality Risk Management per ICH Q9 in support of process design, risk assessments and investigations.
Please reach out directly to email@example.com if interested!
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Recruiter: Jean Chambers
Phone: (410) 579-3072