POSITION PURPOSE
Provide technical leadership and hands-on execution support for Manufacturing-owned remediation activities in an operating sterile fill-finish facility. The consultant will translate regulatory observations and CAPA commitments into scientifically defensible assessments, implementation strategies, technical documentation, and closure-ready deliverables. The role will emphasize sterility assurance, contamination control, cleaning and residue-control programs, qualification and validation strategy, risk assessment, and sustainable remediation execution.
ROLE DISTINCTION
This role complements, and does not duplicate, the aseptic intervention-assessment workstream. The intervention consultant is focused on high-risk intervention families, first-air challenges, contamination mechanisms, and mitigation identification. This consultant will focus on the broader non-intervention remediation portfolio, including technical assessments, scientific justification, validation and qualification strategy, cleaning and contamination-control remediation, implementation support, CAPA documentation, and evidence required for effective closure.
PRIMARY RESPONSIBILITIES
- Support execution of Manufacturing-owned remediation commitments arising from regulatory inspections, third-party assessments, and internal gap evaluations.
- Review assigned CAPAs and translate commitments into clear technical workplans, deliverables, evidence packages, milestones, dependencies, and effectiveness-verification strategies.
- Assess sterility-assurance and contamination-control risks involving facilities, equipment, personnel, and material flow, cleaning and disinfection, component handling, environmental controls, and aseptic support operations.
- Develop or review technical and scientific rationales that demonstrate whether existing controls are adequate, identify when additional controls are needed, and define the evidence necessary to support the conclusion.
- Support contamination-control strategy assessments and updates by linking identified risks to prevention, detection, monitoring, qualification, and lifecycle controls.
- Lead or support cleaning and residue-control assessments, including equipment and change-part cleaning requirements, visual cleanliness expectations, residue/staining/rouging/corrosion escalation logic, cleaning tools, disinfectant application, contact times, and procedural clarity.
- Evaluate remediation actions for technical adequacy, implementation feasibility, validation impact, sustainability, and alignment with the original observation or commitment.
- Develop risk-based qualification and validation strategies, including protocol rationale, worst-case selection, acceptance criteria, implementation sequencing, and impact on existing validated processes.
- Author and review technical assessments, risk assessments, protocols, reports, CAPA action descriptions, CAPA closure packages, effectiveness checks, procedures, work instructions, and management summaries.
- Support investigations and retrospective evaluations by reviewing relevant process history, deviations, environmental or microbiological information, batch documentation, and prior CAPAs to identify patterns and residual risk.
- Coordinate cross-functionally with Manufacturing, QA, Validation, Microbiology, Engineering, MS&T, Facilities, Maintenance, and EHS to obtain evidence, resolve technical decisions, and maintain progress.
- Provide concise status updates, risk escalations, decision requests, and recommendations to the Manufacturing sponsor and remediation governance team.
- Support inspection readiness and preparation of technically accurate materials for regulatory or third-party follow-up discussions when requested.
- Assist with additional aseptic processing, contamination-control, sterility-assurance, and remediation priorities as assigned by Bora Pharmaceuticals.
PRIORITY TECHNICAL WORKSTREAMS
- Remediation and CAPA execution:
- Address multiple technical, cross-functional, and evidence-based commitments.
- Focus on workplan development, technical assessment, deliverable ownership, closure evidence, and effectiveness strategy.
- Cleaning and residue control:
- Tackle procedural clarity, visible residue, staining, rouging/corrosion, and cleaning tools/methods.
- Emphasize gap assessment, scientific rationale, procedure strategy, and support for implementation and effectiveness.
- Sterility assurance / contamination control:
- Connect facility, process, personnel, material, cleaning, and monitoring controls.
- Conduct risk assessment, link to Contamination Control Strategy (CCS), evaluate residual risk, and provide technical recommendations.
- Qualification and validation strategy:
- Manage remediation impacts on qualified equipment, processes, methods, or facility controls.
- Apply risk-based strategy, protocol rationale, worst-case selection, acceptance criteria, and implementation sequencing.
- Scientific justification and documentation:
- Ensure CAPA closure is supported by a complete technical story and objective evidence.
- Prepare assessments, reports, closure packages, management summaries, and inspection-ready traceability.
- Remediation governance support:
- Address execution risks from aggressive timelines and multiple owners.
- Provide status tracking, dependency management, decision escalation, and cross-functional facilitation.
REQUIRED EXPERIENCE AND TECHNICAL CAPABILITIES
- Bachelor’s degree in microbiology, biology, chemistry, pharmacy, engineering, or a related scientific/technical discipline; advanced degree is preferred.
- Approximately 15+ years of progressive experience in sterile pharmaceutical, biologic, vaccine, or aseptic fill-finish manufacturing, quality, sterility assurance, validation, or remediation consulting. Equivalent directly relevant experience may be considered.
- Demonstrated experience supporting FDA remediation, regulatory inspection responses, consent-decree or warning-letter remediation, independent assessments, or large CAPA portfolios within operating sterile manufacturing facilities.
- Deep working knowledge of aseptic processing, sterility assurance, contamination-control strategy, cleanroom operations, first-air principles, RABS/isolators, airflow visualization, environmental monitoring, media fills, cleaning/disinfection, and microbiological risk.
- Demonstrated ability to convert an observation or CAPA commitment into a technically sound assessment, implementation plan, evidence package, and closure strategy.
- Experience developing or reviewing cleaning strategies, residue-risk assessments, cleaning validation or verification approaches, hold-time studies, qualification strategies, and risk-based validation documentation.
- Strong knowledge of GMP quality risk management, CAPA systems, change control, deviation/investigation practices, data integrity, lifecycle management, and effectiveness verification.
- Excellent technical writing skills, including authoring clear scientific rationales, protocols, reports, risk assessments, procedures, CAPA actions, and executive summaries.
- Ability to operate effectively on the manufacturing floor, understand practical constraints, distinguish technical risk from documentation gaps, and propose sustainable solutions.
- Proven cross-functional facilitation and project-execution skills with the ability to work across Manufacturing, Quality, Engineering, Validation, Microbiology, MS&T, Facilities, and senior leadership.
HIGHLY PREFERRED EXPERIENCE
- Former sterility-assurance, contamination-control, quality, validation, microbiology, or remediation leadership role supporting commercial sterile drug-product operations.
- Experience developing or remediating a site Contamination Control Strategy under EU GMP Annex 1 principles.
- Experience with vial, syringe, lyophilization, sterile filtration, component preparation, clean utilities, and aseptic support operations.
- Experience with equipment/change-part cleaning, disinfectant programs, visual cleanliness, residue/staining/corrosion assessments, and cleaning-related CAPAs.
- Experience defining validation impact and qualification strategy for remediation changes without unnecessarily expanding scope beyond the observation or commitment.
- Experience preparing organizations for FDA follow-up meetings, regulatory inspections, third-party verification, or independent remediation assessments.
- Experience managing multiple concurrent CAPAs with aggressive deadlines and interdependent technical deliverables.
EXPECTED DELIVERABLES
- Prioritized remediation workplan for assigned CAPAs, including milestones, dependencies, owners, evidence needs, and decision points.
- Technical gap assessments and risk assessments linked directly to observations, commitments, current controls, and residual risk.
- Scientific rationale documents and recommendation memoranda supporting remediation decisions.
- Cleaning, contamination-control, sterility-assurance, qualification, and validation strategies for assigned workstreams.
- Draft or revised SOPs, work instructions, protocols, reports, and supporting technical documentation as required.
- CAPA action descriptions, completion evidence, closure packages, and effectiveness-verification plans.
- Cross-functional meeting outputs, decision logs, issue escalations, and concise weekly sponsor updates.
- Inspection-ready traceability showing the connection between the original observation, root issue, corrective action, implementation evidence, and sustained effectiveness.
WORKING CONDITIONS
- Full-time contractor assignment with significant on-site presence in Baltimore during onboarding, facility familiarization, and activeremediation execution.
- Approximately 40 hours per week; hours above the standard workweek require prior Bora approval.
- Hybrid support may be considered after priorities, deliverables, and working relationships are established.
- Work in classified and controlled manufacturing areas in accordance with gowning, safety, and site requirements.
- Occasional off-hours support may be needed for manufacturing observation, protocol execution, implementation, or remediation milestones.
- Engagement duration will be aligned to agreed remediation objectives and deliverables; commercial and termination terms will be defined separately in the applicable agreement.