Senior Engineering Manager

York, United States | Posted on 10/22/2026

Bio Technique is a sterile injectable full service CDMO providing cytotoxic and therapeutic sterile injectable fill-finish services. From IND applications through commercial scale production, we provide formulation and compounding, fill-finish, and lyophilization services for a wide variety of liquid injectables. Bio Technique utilizes our team’s expertise to create a process design for our clients’ products that best suits their needs.

With operations spanning the globe and featuring a multi-cultural team, Bio Technique is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.

We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered a compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.

At Bio Technique, it’s about more than just a job—it’s about your career and your future.

The Senior Engineering Manager is responsible for leading the Validation Engineers and Process Engineers at the Bio Technique CDMO site. This role oversees the startup, commissioning, qualification, validation, and continuous operation of process equipment, utilities, and systems to ensure safe, compliant, and efficient pharmaceutical manufacturing operations supporting clinical and commercial products.

• Oversee the startup and continuous operation of process equipment, utilities, and facility systems supporting sterile manufacturing operations, ensuring compliance with regulatory requirements and industry standards.
• Work with multiple departments on engineering and validation issues across the site and support equipment troubleshooting.
• Monitor and analyze process performance data, implementing corrective actions as needed to maintain consistent and reliable operations.
• Develop and manage project timelines, budgets, and resources for new equipment startup, ensuring projects are completed on time and within budget.
• Establish and maintain strong relationships with equipment vendors and contractors.
• Lead and execute Commissioning, Qualification, and Validation (CQV) activities for equipment, utilities, processes, and systems across the site.
• Ensure validation lifecycle activities (e.g., IQ/OQ/PQ, process validation, cleaning validation) meet cGMP and regulatory requirements.
• Manage the current state of the Site Validation Master Plan and support development of the electronic Site Validation Master Plan in ACE®.
• Perform and manage validation execution activities at the site to ensure that no equipment goes overdue with its revalidation cycle.
• Review validation documentation for equipment, processes, and systems.
• Ensure that all validation and process engineering activities are documented in ACE® or Kneat Paperless Validation System.
• Maintain compliance with FDA, EU, cGMP, and global regulatory standards, as well as all relevant safety, health, and environmental regulations, promoting a culture of safety within the team.
• Support quality investigations of validation/process deviations, GMP issues, system issues, and CAPAs.
• Conduct risk assessments, failure mode and effects analysis (FMEA), and root cause investigations to identify and mitigate potential issues with existing and new equipment at the site.
• Review technical and investigation reports as appropriate.
• Provide support for proposed changes to systems, procedures, and methods, as…