Senior Aseptic Process Engineer

Job Description

Job Description

Job Title: Senior Aseptic Process Engineer Job Description

The Senior Aseptic Process Engineer will lead the technical evaluation, design, and implementation of improvements to legacy aseptic filling and setup practices, with a strong focus on reducing contamination risk and modernizing fill-finish operations. This role receives prioritized technical findings from aseptic intervention assessments and translates them into practical engineering solutions, working closely with vendors and cross-functional site teams. The engineer will own the full lifecycle of selected solutions, from feasibility and design through integration, qualification, and handover to routine operations in a sterile drug product manufacturing environment.

• Assess legacy aseptic filling and setup practices at the equipment and component level, including open aseptic connections, sterile filtration assemblies, receiving vessels, fill-line assemblies, product-contact nozzles, tubing routing, manual component installation, and intervention-prone equipment interfaces.
• Translate contamination mechanisms and intervention-risk findings into specific engineering user requirements, design concepts, alternative configurations, and detailed implementation plans.
• Lead the technical evaluation of single-use bags, tubing assemblies, sterile and aseptic connectors, quick-connect systems, preassembled filtration manifolds, clamps, fittings, protective covers, tubing-management devices, and closed-product-pathway options.
• Engage directly with component and single-use-system vendors to identify commercially available solutions, obtain samples and technical data, compare alternatives, conduct fit and compatibility reviews, and develop custom assemblies when off-the-shelf options are not sufficient.
• Develop current-state and future-state process flow diagrams, assembly drawings, tubing schematics, P&IDs/PFDs where applicable, component lists, design specifications, and User Requirements Specifications.
• Evaluate integration of proposed solutions into existing legacy filling lines, open RABS/Lexan configurations, sterilization methods, autoclave loads, material-transfer practices, formulation interfaces, and manufacturing workflows.
• Assess product-contact material compatibility, sterilization compatibility, hold-up volume, flow characteristics, pressure limits, filter configuration, extractables and leachables needs, integrity requirements, connection robustness, and supply-chain continuity in collaboration with appropriate site subject matter experts.
• Design and execute bench-top trials, mockups, engineering studies, and vendor demonstrations to verify usability, operator access, assembly sequence, ergonomics, first-air protection, and reduction of open exposure prior to formal implementation.
• Partner with Manufacturing, MS&T, Quality Assurance, Validation, Microbiology, Maintenance, Procurement, and EHS to define change-control requirements, qualification and validation strategies, smoke-study and media-fill impacts, training needs, and procedural updates.
• Prepare comprehensive feasibility assessments, option comparisons, cost estimates, schedules, technical recommendations, and phased implementation roadmaps that cover quick wins, medium-term modifications, and capital improvements.
• Support procurement activities, vendor selection, design reviews, factory and site acceptance testing, commissioning, installation, protocol development, execution, and turnover to routine operations.
• Provide technical ownership through implementation and effectiveness verification, confirming that implemented solutions reduce intervention frequency, manual manipulation, open-exposure time, first-air disruption, and direct glove interaction with sterile product-contact surfaces.
• Contribute to process development and continuous improvement initiatives related to sterile drug product manufacturing, aseptic interventions, and fill-finish operations.
• Support audit readiness and regulatory expectations by aligning improvements with GMP, FDA guidance, Annex 1, and site-specific CAPA and remediation activities.
• Develop and maintain clear engineering documentation, process maps, and risk assessments to support compliance, quality assurance, and ongoing process optimization.

• Bachelors degree in Chemical, Mechanical, Biochemical, Biomedical, Manufacturing, or a related engineering discipline; an advanced degree is a plus.
• Approximately 10+ years of experience in process engineering, manufacturing engineering, MS&T, equipment engineering, or process development within sterile pharmaceutical or biologic manufacturing; equivalent depth of directly relevant experience may be considered.
• Demonstrated hands-on experience improving or modernizing legacy aseptic filling and fill-finish operations, rather than solely designing new greenfield systems.
• Direct experience with vial and/or syringe filling, sterile filtration, product-transfer assemblies, tubing sets, product-contact components, RABS or isolator operations, and manual aseptic setup practices.
• Strong practical understanding of first-air protection, unidirectional airflow, critical surfaces, open product pathways, intervention design, contamination mechanisms, and the hierarchy of engineering controls.
• Proven experience implementing or evaluating single-use bags, tubing manifolds, sterile and aseptic connectors, quick-connect technologies, disposable product pathways, and vendor-supplied custom assemblies.
• Experience engaging suppliers of single-use systems, connectors, filtration components, tubing, bags, clamps, and sterile fluid-transfer solutions.
• Working knowledge of applicable GMP engineering and design expectations, including change control, design qualification, commissioning and qualification, process validation, aseptic process simulation, airflow visualization, and product-contact material assessment.
• Ability to develop and maintain engineering documentation such as process flow diagrams, P&IDs, tubing schematics, layouts, equipment specifications, User Requirements Specifications, option analyses, protocols, and technical reports.
• Capability to work effectively on the manufacturing floor, observe manipulations at a granular level, ask probing technical questions, develop physical mockups, and translate observations into practical engineering solutions.
• Technical expertise in aseptic processing, fill-finish operations, single-use systems, aseptic interventions, sterile drug product manufacturing, process development and improvement, and risk assessments.
• Familiarity with quality assurance, compliance, GMP, FDA expectations, 483 observations, CAPA and ICP activities, Annex 1, and aseptic process remediation and enhancements.
• Ability to interpret and contribute to process maps and structured remediation or improvement projects related to aseptic processing and RABS enhancements.

• Advanced engineering degree in a relevant discipline is considered an advantage.
• Experience supporting or responding to regulatory inspections, FDA remediation efforts, and formal CAPA or improvement projects related to aseptic processing.
• Exposure to structured projects or investigations (such as CAPA and improvement initiatives) that address aseptic interventions, RABS enhancements, and process robustness.
• Strong analytical and problem-solving skills with the ability to compare technical options, evaluate feasibility, and recommend phased implementation strategies.
• Effective communication and collaboration skills to work with cross-functional teams, vendors, and site subject matter experts.
• Comfort with developing and using process maps, engineering studies, and technical documentation to support continuous improvement.
• Motivation to contribute to a modernizing facility and help drive change in aseptic and fill-finish operations.

This is a full-time contractor assignment with significant on-site presence in a manufacturing facility located in Baltimore. The role operates primarily in classified and controlled manufacturing areas, following established gowning, safety, and site requirements. The standard schedule is Monday through Friday, approximately 9:00 a.m. to 5:30 p.m., with the flexibility to support occasional off-hours manufacturing observations, vendor testing, implementations, or qualification activities as needed. The position involves extensive work in aseptic manufacturing areas, including fill-finish operations and RABS or isolator environments, where adherence to aseptic techniques and controlled-environment procedures is critical. The engineer will frequently interact with manufacturing personnel, vendors, and cross-functional teams on the shop floor to observe operations, conduct trials, and support workshops. Travel may be required for vendor visits, factory acceptance tests, technical evaluations, and supplier collaboration. The environment offers the opportunity to contribute to a new or modernizing facility and to help drive meaningful process and equipment changes that enhance aseptic performance and compliance.

This is a Contract position based out of Baltimore, MD.

The pay range for this position is $100.00 - $125.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Baltimore,MD.

This position is anticipated to close on Oct 19, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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