Aseptic Production Consultant

Job Title: Aseptic Manufacturing Consultant

Location: Albany, NY – Local Candidates Preferred

Employment Type: W2 Contract – 6 Months with Possibility for Extensions

Pay Rate: Based on Experience

Work Model: Hybrid – Remote Consulting with Required Onsite Travel

Travel Requirements: Travel to the Albany, NY facility based on operational and business needs

Benefits: Medical, Dental, Vision, and Life Insurance

Note: This is a W2 only role — C2C and C2H will not be considered.

Important Application Requirement: Candidates must submit responses to the five prescreening questions included below, along with redacted examples demonstrating direct, hands-on aseptic manufacturing experience. Applications should not include confidential, proprietary, or personally identifiable information.

Role Overview

BEPC is seeking an experienced Aseptic Manufacturing Consultant to support our customer's sterile pharmaceutical manufacturing operations in Albany, NY.

This position focuses on aseptic process development, sterile injectable manufacturing, media fills, smoke studies, equipment qualification, and operator training for ready-to-use prefilled syringes and IV bags.

The successful candidate will provide technical leadership and practical guidance to the General Manager and production operators as they establish reliable aseptic manufacturing workflows, develop manufacturing documentation, qualify personnel, and prepare for engineering batches and media-fill activities.

This is a hands-on consulting opportunity that combines remote technical support with required onsite travel to guide manufacturing setup, operator training, process qualification, and production readiness.

The ideal candidate brings at least 7 years of direct, hands-on sterile injectable manufacturing experience, preferably within a 503B outsourcing facility, hospital sterile compounding operation, or pharmaceutical fill-finish environment.

Candidates must demonstrate practical experience establishing aseptic manufacturing processes—not solely reviewing documentation or providing quality oversight.

Key Responsibilities

Aseptic Manufacturing & Process Development

• Lead and guide the establishment of aseptic production workflows for ready-to-use prefilled syringes and IV bags.
• Develop practical manufacturing processes that support consistent, repeatable sterile production.
• Establish appropriate personnel flow, material flow, gowning procedures, and aseptic handling practices.
• Provide technical guidance on contamination prevention and proper aseptic techniques.
• Evaluate proposed manufacturing workflows and recommend improvements to support production readiness.
• Identify operational gaps and assist management in implementing practical corrective actions.
• Support the transition from initial process setup through engineering batch execution.

Equipment Setup & Process Qualification

• Provide technical guidance on the selection, setup, and appropriate use of sterile manufacturing equipment, including:
• Laminar airflow hoods
• Repeater pumps
• Sterilizing filters
• Sterile filling equipment and associated processes
• Support equipment setup and readiness activities for aseptic manufacturing.
• Guide equipment qualification and process qualification activities.
• Identify equipment-related risks and recommend improvements to manufacturing processes.
• Collaborate with production and quality personnel to ensure equipment and processes support intended sterile manufacturing operations.
• Provide hands-on technical support during onsite equipment and process activities.

Media Fills & Smoke Studies

• Design and support media-fill activities (aseptic process simulations).
• Guide the execution, documentation, and evaluation of media fills in collaboration with manufacturing and quality personnel.
• Ensure media-fill activities appropriately represent intended aseptic manufacturing operations.
• Provide technical guidance on smoke studies and airflow visualization activities.
• Support the execution, evaluation, and documentation of smoke studies.
• Identify potential aseptic processing risks and recommend improvements based on study observations.
• Help establish repeatable procedures for ongoing aseptic process evaluation.

Manufacturing Documentation & SOP Development

• Develop, review, and improve Standard Operating Procedures (SOPs) for sterile manufacturing activities.
• Prepare manufacturing instructions and batch production records.
• Establish clear, practical documentation for aseptic production workflows.
• Support documentation for equipment setup, operator activities, media fills, and engineering batches.
• Collaborate with operations and quality teams to address documentation gaps.
• Ensure procedures are understandable and usable by production operators.
• Support consistent execution of manufacturing activities through standardized instructions.

Operator Training & Qualification

• Provide practical coaching and technical guidance to the General Manager and production operators.
• Train personnel on proper gowning procedures, aseptic technique, and sterile handling practices.
• Support operator qualification activities related to aseptic manufacturing.
• Demonstrate proper manufacturing techniques and provide feedback on operator performance.
• Identify training gaps and recommend targeted improvements.
• Help establish a capable production team prepared to perform consistent aseptic manufacturing operations.
• Translate complex technical requirements into clear, actionable instructions for manufacturing personnel.

Engineering Batches & Production Readiness

• Plan and support engineering batch activities for sterile injectable manufacturing.
• Provide technical guidance during initial manufacturing runs.
• Evaluate process execution and identify opportunities for improvement.
• Collaborate with manufacturing and quality personnel to address operational challenges.
• Recommend adjustments to improve process consistency, documentation, and production readiness.
• Support the establishment of repeatable aseptic production practices.
• Assist management in preparing manufacturing operations for ongoing sterile production activities.

Remote Consulting & Onsite Support

• Provide technical consultation remotely to support ongoing manufacturing setup and process development.
• Travel to the Albany, NY facility as required for hands-on manufacturing activities.
• Conduct onsite coaching, operator training, and process assessments.
• Support critical onsite activities involving equipment setup, qualification, media fills, smoke studies, and engineering batches.
• Maintain clear communication with management and production personnel.
• Work independently while coordinating effectively with cross-functional stakeholders.
• Provide practical recommendations to support operational decisions and manufacturing readiness.

Required Qualifications

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biology, Biotechnology, Engineering, or a related scientific or technical field.
• Minimum 7 years of hands-on experience producing sterile injectables through aseptic processing in one or more of the following environments:
• 503B outsourcing facilities
• Hospital sterile compounding operations
• Pharmaceutical fill-finish manufacturing
• Direct experience setting up aseptic manufacturing processes, including establishing sterile production workflows.
• Hands-on experience designing, executing, or supporting media fills (aseptic process simulations).
• Direct experience with smoke studies in aseptic manufacturing environments.
• Practical experience with equipment qualification and/or process qualification for sterile manufacturing operations.
• Experience manufacturing prefilled syringes and/or IV bags.
• Strong understanding of aseptic production workflows, gowning practices, and sterile handling procedures.
• Experience training and supporting the qualification of aseptic manufacturing operators.
• Practical knowledge of:
• Laminar airflow hoods
• Repeater pumps
• Sterilizing filters
• Sterile filling processes
• Experience developing and reviewing manufacturing SOPs, work instructions, and batch records.
• Experience supporting engineering batches and identifying process improvements.
• Ability to provide clear, practical technical guidance to manufacturing management and production operators.
• Strong analytical, troubleshooting, and problem-solving skills.
• Excellent written and verbal communication skills.
• Ability to work independently in a consulting capacity.
• Ability to manage technical priorities and collaborate with manufacturing and quality teams.
• Willingness and availability to travel to the Albany, NY facility as required.
• Ability to provide specific, redacted examples of direct hands-on experience with aseptic process setup, media fills, smoke studies, qualification activities, and prefilled syringe or IV bag manufacturing.

Preferred Qualifications

• Experience supporting the startup, launch, or establishment of sterile manufacturing operations.
• Experience guiding sterile manufacturing operations from initial process development through production readiness.
• Experience establishing new aseptic manufacturing workflows and training production teams.
• Experience partnering with quality personnel to address documentation, training, or process deficiencies.
• Experience supporting multiple phases of sterile injectable manufacturing setup, including equipment readiness, qualification, media fills, and engineering batches.
• Previous consulting experience in sterile pharmaceutical manufacturing or aseptic production.
• Experience providing practical technical leadership to manufacturing managers and production operators.
• Candidates located in Albany, NY, or surrounding areas are preferred due to onsite travel requirements.

Prescreening Questions – Required for Consideration

Candidates must answer all five questions and provide specific, redacted examples demonstrating their personal, hands-on involvement.

Responses should be included directly in the resume or submitted as an accompanying document.

1. Aseptic Process Setup

Please describe your direct hands-on experience setting up aseptic manufacturing processes.

Include:

• The type of sterile manufacturing environment.
• Your specific responsibilities.
• An example of an aseptic production process you helped establish or implement.
• Your personal involvement in developing manufacturing workflows or aseptic handling practices.

2. Media Fills (Aseptic Process Simulations)

Have you directly designed, executed, or supported media-fill activities?

Please provide a specific example describing:

• The type of media-fill activity.
• Your role and responsibilities.
• The activities you personally performed.
• Your involvement in execution, documentation, or evaluation.

3. Smoke Studies

Please describe your direct experience with smoke studies in an aseptic manufacturing environment.

Include:

• The type of smoke study performed.
• Your role in execution, evaluation, or documentation.
• Your specific hands-on contributions.
• A redacted example demonstrating your experience.

4. Equipment or Process Qualification

What hands-on experience do you have with equipment qualification and/or process qualification in sterile manufacturing?

Please identify:

• The equipment or manufacturing processes involved.
• The type of qualification activity.
• Your direct responsibilities.
• Your personal contributions to qualification activities.

5. Prefilled Syringes or IV Bags

Do you have direct manufacturing experience with prefilled syringes and/or IV bags?

Please specify:

• Which products you have manufactured.
• The sterile manufacturing processes involved.
• Your responsibilities during production.
• Your direct hands-on involvement in aseptic filling or related manufacturing activities.

Confidentiality Requirement: All examples must be appropriately redacted. Do not include confidential business information, proprietary manufacturing details, patient information, or personally identifiable information.

Important: Responses must demonstrate direct hands-on experience. General descriptions of team activities, supervisory oversight, or quality review responsibilities alone may not sufficiently demonstrate the required technical expertise.

This consulting position involves a combination of remote technical guidance and onsite manufacturing support.

The successful candidate should be comfortable:

• Providing independent technical consultation on aseptic manufacturing processes.
• Traveling onsite to support critical sterile production activities.
• Working directly with manufacturing management and production operators.
• Demonstrating aseptic manufacturing techniques and coaching personnel.
• Supporting equipment setup, qualification, media fills, and smoke studies.
• Developing manufacturing documentation and operator training procedures.
• Assisting with engineering batches and production readiness activities.
• Identifying process gaps and implementing practical improvements.

About BEPC

BEPC Inc., founded in 2007, is a 100% employee-owned company providing top-tier consulting and staffing solutions across industries like technology, engineering, manufacturing, and project management. At BEPC, we are driven by innovation and a commitment to excellence. We take pride in fostering a collaborative and innovative environment where our team members thrive. With competitive benefits, including medical, dental, vision, and life insurance, BEPC is dedicated to supporting our employees' personal and professional growth.

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