Aseptic Production Consultant - Life Sciences

BEPC is actively seeking an Aseptic Production Consultant in Albany, NY!

W2 Contract Duration: 6 months, with possible extensions!
Location: Albany, NY – Local candidates preferred
Work Model: Hybrid –with required onsite travel
Travel Requirements: Travel to the Albany, NY facility is required based on business and operational needs.

Important: To apply for this position, candidates are required to include answers to the questions below for consideration. Please provide redacted examples demonstrating direct hands-on experience with aseptic process setup, media fills, smoke studies, equipment or process qualification, and prefilled syringes or IV bags. Please do not include confidential, proprietary, or personally identifiable information.

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

Summary of the Role:

BEPC is seeking a highly motivated Aseptic Production Consultant to support our client’s sterile manufacturing operations in Albany, NY. This role will support aseptic production for ready-to-use syringes and IV bags, with remote consulting responsibilities and required onsite travel.

The consultant will guide the general manager and production operators through establishing aseptic production workflows, preparing manufacturing documentation, and developing the technical skills needed to support sterile manufacturing operations.

The ideal candidate brings extensive hands-on experience in sterile injectable manufacturing, aseptic process setup, media fills, smoke studies, equipment or process qualification, and prefilled syringes or IV bags.

This role will help establish a trained production team, documented manufacturing processes, and repeatable aseptic production practices to support media-fill activities and engineering batches.

Main Duties and Responsibilities:

• Guide the development of aseptic production workflows for ready-to-use syringes and IV bags, including personnel and material flow, gowning, and aseptic handling practices.
• Advise on the selection, setup, and appropriate use of production equipment, including laminar airflow hoods, repeater pumps, and sterilizing filters.
• Develop and review manufacturing instructions, standard operating procedures (SOPs), and batch records.
• Train and support the qualification of operators in gowning and aseptic technique.
• Design media-fill simulations and guide their execution, documentation, and evaluation in collaboration with operations and quality personnel.
• Support aseptic process setup, smoke studies, and equipment or process qualification activities.
• Plan and support engineering batches, identify process gaps, and recommend improvements.
• Provide practical coaching to the general manager and production operators to establish consistent and repeatable manufacturing practices.
• Deliver remote consulting support and travel to the Albany, NY facility as required to support manufacturing operations, operator training, process development, and production activities.

Main Qualifications: 

• Education: Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Biology, Biotechnology, Engineering, or a related scientific or technical field.
• Experience: Minimum of 7 years of hands-on experience producing sterile injectables through aseptic processing in a 503B outsourcing facility, hospital sterile compounding operation, or pharmaceutical fill-finish environment.
• Direct hands-on experience with aseptic process setup, including establishing sterile manufacturing workflows and aseptic handling practices.
• Experience designing, executing, or supporting media fills (aseptic process simulations).
• Direct experience with smoke studies in aseptic manufacturing environments.
• Hands-on experience with equipment and/or process qualification in sterile manufacturing operations.
• Experience manufacturing prefilled syringes and/or IV bags.
• Demonstrated experience with aseptic production workflows, gowning practices, operator training, and qualification.
• Practical knowledge of laminar airflow hoods, repeater pumps, sterilizing filters, and sterile filling processes.
• Experience developing manufacturing procedures, SOPs, and batch records.
• Experience supporting engineering batches and identifying process improvements.
• Ability to translate technical requirements into clear, practical instructions for managers and production operators.
• Ability to work independently in a remote consulting capacity, with willingness and availability to travel to the Albany, NY facility as required.

Preferred Qualifications: 

• Previous experience supporting the launch or establishment of sterile manufacturing operations.
• Experience supporting sterile manufacturing operations from initial process development through production readiness.
• Experience partnering with quality teams to address documentation, training, and process deficiencies.
• Candidates residing in Albany, NY, or surrounding areas are preferred due to onsite travel requirements.

Candidate Questions (to Be Answered on Resume): 

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, and an example of a process you helped establish or implement.
2. Media Fills (Aseptic Process Simulations): Have you directly designed, executed, or supported media-fill activities? Please provide a specific example describing your involvement, responsibilities, and the activities performed.
3. Smoke Studies: Please describe your direct experience with smoke studies in an aseptic manufacturing environment. What was your role in their execution, evaluation, or documentation? Provide a redacted example.
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 processes involved and describe your direct contributions.
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 worked with, the manufacturing processes involved, and your responsibilities.

Application Requirement: Candidates should include their responses and relevant redacted examples directly in their resumes or as an accompanying document. Responses should clearly demonstrate their personal, hands-on involvement in the activities described above.

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.

Apply Now!

Qualified candidates are encouraged to apply by submitting an up-to-date resume that highlights how your experience aligns with the role. Please include specific examples that demonstrate your qualifications. We look forward to connecting with you!

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.