• $80,000 - $110,000 p
• Client sites across the U.S. (Relocation required)
• December 2023

Job Responsibilities:

• Evaluate the safety, efficiency, and effectiveness of biomedical equipment.
• Review and approve design specifications, design verification, and validation protocols; facilitate and participate in design reviews, developing quality engineering deliverables.
• Conduct root cause analysis and statistical risk assessments using analysis software.
• Prepare regulatory and compliance documentation, including risk assessments and preliminary hazard analysis documents.
• Coordinate risk management activities for medical devices per ISO standards and FDA regulations.
• Develop and maintain Requirement Traceability Matrix (RTM) linking functionality to verification and validation documents, including authoring and reviewing DHF files.
• Ensure compliance of quality systems with CFR 820 and ISO 13485.
• Support technology transfer processes by preparing comprehensive quality documentation, including sampling plans, process controls, test methods, and engineering studies.
• Perform time and motion studies, failure mode effects analysis (FMEA), and other quality engineering analyses.
• Collaborate with the Regulatory Department on product submissions, regulatory issues (e.g., 510(k)s, labeling, complaints, FDA Medical Device Reporting).
• Complete preliminary and final regulatory assessments and develop regulatory strategies.
• Implement electronic submission databases for global submissions adhering to EU e-CTD requirements.
• Prepare and submit changes to European Notified Bodies, including significant change supplements or notifications.
• Author and submit 510(k)s to the FDA for device changes that require clearance.
• Compile materials for worldwide pre-market and post-market regulatory submissions, license renewals, and annual registrations in compliance with 21 CFR, EU Medical Device Directives, and other global regulations.

Qualifications:

• Bachelor’s Degree in Engineering (Mechanical, Chemical, Electrical, Biomedical, Biotechnology, Electronics, Manufacturing, Industrial, Technology Management, Engineering Management, Information Technology/Systems) or related fields.
• Alternatively, degrees in Regulatory Affairs, Biology, Chemistry, Pharmacy, Pharmacology, or related fields are acceptable.
• Must be flexible for relocation to client sites on short notice.

Application Process:

• Candidates will be tested on their capability to perform the tasks mentioned above.
• Email resumes to hr@revereit.com.

• $80,000 - $110,000 p
• Client sites across the U.S. (Relocation required)
• December 2023

Job Responsibilities:

• Interpret and communicate FDA regulations and changes across corporate policies and procedures (21 CFR 820, ISO 13485, ISO 14971).
• Develop and implement programs to evaluate analytical testing, equipment, facilities, and performance testing.
• Author and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols, including Traceability Matrix development per SOPs.
• Conduct process performance and capability analyses to assess variability.
• Initiate CAPAs for deviations, non-conformance, and non-compliance issues.
• Perform statistical analyses (e.g., Gage R&R, ANOVA, MINITAB) to identify root causes of deviations.
• Document corrections and removals as needed.
• Ensure quality, design, and development plans, as well as V&V plans and protocols, align with FDA regulations and company standards.
• Generate metrics and communicate them for quality and compliance management reviews.
• Prepare system requirement specifications for validation processes.
• Develop regulatory deliverable timelines and schedules for assigned projects and design control activities.
• Create validation master plans, process flow diagrams, test cases, and standard operating procedures.
• Prepare validation/performance qualification protocols for new or modified processes and equipment.
• Maintain validation activity databases and documentation for test results and procedures.
• Identify required regulatory submissions or documentation for device and labeling changes.

Qualifications:

• Bachelor’s Degree in Regulatory Affairs, Biology, Chemistry, Biotechnology, Pharmacy, Pharmacology, or related Engineering disciplines (Mechanical, Chemical, Electrical, Biomedical, Biotechnology, Electronics, Manufacturing, Industrial, Technology Management, Engineering Management).
• Must be willing to relocate to client sites on short notice.

Application Process:

• Candidates will be evaluated on their general ability to perform outlined responsibilities.
• Email resumes to hr@revereit.com.

• 5 Minimum
• NA
• Parsippany, NJ
• 1 Day ago

Qalifications:
Process Engineer should possess at a minimum five (5) years of experience in pharmaceutical support, process engineering and process validation.  Knowledge of EMEA (Annex 1) and FDA (21CFR200s, 210s, 600s)
 

CAPA closure on an FDA BPDR (239368)
Complete engineering feasibility study to determine if sonication capabilities can be added upstream of vial washer.
Perform engineering study on vial washer using riboflavin and potentially microsphere suspensions and develop washing cycle if required.
Annex 1 Gap Remediation
Number of Cycles for Air Filters (Process Engineer) – we currently replace air filters every six months during our shutdown.  Create justification for maximum duration of use on vent filters and create integrity testing for pre-use and captured as part of the changeout.  Process equipment should have a defined number of cycles that can be captured between changeout of filters.
Bubble room (HVAC Engineer):  Require rationale for the need of the bubble room and justify the alarm setpoints between each grade throughout the suite.  Feasibility study to determine if clean room suite air supply can be retrofitted to supply air that maintains positive pressure and remove the need for the bubble roo

• NA
• Colorado
• 1 Day ago

Key Responsibilities:

Develop and execute validation plans, protocols (IQ, OQ, PQ), and reports for equipment, processes, and software used in the manufacturing of medical devices.

Conduct risk assessments and create risk mitigation plans.

Ensure compliance with relevant regulatory standards (e.g., FDA, ISO 13485, and EU MDR).

Maintain documentation to support regulatory submissions and audits.

Validate manufacturing processes, including sterilization, packaging, and labeling.

Perform process capability studies and ensure process robustness.

Qualify new and existing equipment, ensuring it meets performance specifications.

Conduct routine calibration and maintenance activities.

Validate software used in the design, development, and manufacturing of medical devices.

Ensure compliance with software validation standards and guidelines.

Analyze validation data, identify trends, and recommend corrective actions.

Use statistical tools to support validation activities and decision-making.

Documentation:

Prepare and maintain validation documentation, including protocols, reports, and standard operating procedures (SOPs).

Ensure all documentation is accurate, complete, and audit-ready.

Work closely with R&D, Quality Assurance, Manufacturing, and Regulatory Affairs teams to ensure validation activities align with project goals and regulatory requirements.

Provide validation support during product development and scale-up activities.

Identify opportunities for process improvements and implement best practices in validation.

Stay updated with industry trends, advancements, and changes in regulatory requirements.

Skills and Qualifications:

Education: Bachelor’s degree in Engineering, Biomedical Engineering, or a related field.

Experience: 3-5 years of experience in validation engineering, preferably in the medical device industry.

Technical Skills:

Proficiency in validation protocols and methodologies (IQ, OQ, PQ).

Knowledge of regulatory standards (e.g., FDA 21 CFR Part 820, ISO 13485).

Familiarity with statistical analysis tools and software (e.g., Minitab).

Understanding of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).