Job Description

We are seeking an experienced consultant with deep expertise in sterile drug product (DP) filling operations and automation equipment for pre-filled syringes. This role will support our team during ongoing GMP fill/finish campaigns, helping troubleshoot equipment-related challenges, optimize processes, and ensure compliance with regulatory expectations.

This is a part-time consulting role, ideal for a senior-level professional who can step in as a hands-on technical SME and strategic advisor to our CMC and manufacturing teams.

Responsibilities

• Provide technical troubleshooting and guidance on syringe fill/finish automation equipment during GMP runs (e.g., Bausch+Ströbel, Syntegon/Bosch, Optima, Vanrx).
• Collaborate with CMC, process development, and manufacturing teams to resolve equipment performance issues impacting yield, quality, or throughput.
• Review and advise on batch records, deviations, CAPAs, and equipment qualification documentation related to sterile filling.
• Support root cause analysis and corrective actions for issues such as misfills, plunger placement, stopper insertion, vacuum/pressure fluctuations, and particulate control.
• Provide expert input on technology transfer, scale-up, and PPQ strategies for pre-filled syringe operations.
• Ensure all activities align with GMP, FDA, EMA, and Annex 1 guidance.
• Serve as a trusted advisor to leadership on fill/finish strategy, risk mitigation, and process robustness.

Qualifications

• 10+ years’ experience in sterile drug product manufacturing, CMC, or process development with a focus on fill/finish operations.
• Demonstrated expertise in aseptic filling of pre-filled syringes.
• Hands-on experience with automation platforms (Bausch+Ströbel, Bosch/Syntegon, Optima, Vanrx, or similar).
• Proven ability to troubleshoot and optimize equipment performance during GMP runs.
• Strong working knowledge of GMP regulations, Annex 1, and FDA guidance for sterile manufacturing.
• Experience with technology transfer, validation, and PPQ for syringe filling strongly preferred.
• Excellent problem-solving, communication, and collaboration skills.
• Advanced degree in engineering, pharmaceutical sciences, or related discipline preferred.

Location

• Combination of remote support and on-site presence during critical GMP activities.

Employment Type

• Part-time consulting basis (hours flexible depending on project needs).

Compensation

• $100-$250/hour  

About Ventura Solutions

Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp to permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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