Director of Engineering

Summary of Primary Responsibilities:

This position is responsible for leading the Bedford Site’s Validation/Engineering programs for new/existing products and cGXP systems including process equipment, utilities, and information systems according to current Good Manufacturing Practices (cGMP), ISO requirements, and ICH guidelines. Reporting to the Executive Director, Operations, this position works internally across the Anika organization to define, administer, and continuously improve the site’s validation, process, and packaging engineering system. The incumbent will manage master service agreements with multiple external validation and engineering service partners, and also manage contract staff and Engineering resources.

Responsibilities:

• Manages the site validation/engineering programs ensuring timely execution of all projects, activities, and schedules including re-validation requirements thru accurate requirements definition and resource planning.
• Oversees the generation, execution, and summary of engineering studies, commissioning, and qualification protocols for GXP systems including equipment/test instruments, utilities, processes, and IT systems.
• Manages the investigation, impact assessment and resolution for all validation and engineering non-conformances.
• System owner of the site’s validation and engineering program; drafts, defines, and revises submission packets, procedures to ensure compliance to cGMP, GLP, FDA and worldwide regulations.
• Establishes key performance indicators in alignment with company and operational goals; maintain and report applicable department and system metrics.
• Leads and/or supports Strategic Technical project or new capital project teams by defining technical requirements, resource requirements budgets and timelines.
• Provides general technical expertise on new equipment and modification to existing equipment to ensure validation/qualification status is maintained in a state of control.
• Proactively identify, assess, and mitigate operational and organizational risks; escalate key risks and issues.
• Responsible for department’s annual operating budgets and Capex budgets; partner with Finance to analyze variances and implement adjustments as needed.
• Performs other related duties as required.

Job Complexity:

The job requires the ability to act on problems of diverse and highly technical scope, requiring critical thinking and interaction with internal and external technical professionals.

Implements strategic policies and adheres to budgets, schedules, work plans, and performance requirements. The position exercises broad judgment within generally defined practices and policies and exercises analytical decision-making abilities.

Supervisory Responsibilities:

Supervisory responsibility for engineering staff.

Experience, Knowledge, and Skills Required:

• Bachelor's degree in engineering or life sciences or equivalent experience.
• 8+ years of validation/engineering experience in pharmaceuticals or medical devices
• Master’s degree preferred
• Expertise in FDA, EMA, and ICH qualification/validation requirements and creative risk-based approaches for meeting and exceeding the minimum requirements.
• Demonstrated situational leadership skills and project management expertise; ability to plan complex projects and accurately assess and manage resource requirements.
• Thorough understanding of key supporting quality systems including change control, deviation / non-conformance, and CAPA. Expertise in root cause analysis.
• Knowledge of aseptic processing and/or process optimization and process scaling
• Experience with formulating and processing viscous solutions or tissue-based extraction/purification a plus.
• Excellent analytical and problem-solving skills coupled with strong presentation skills. Excellent communication skills, both verbal and written.

Desired Experience, Knowledge, and Skills:

• Working knowledge using Kaye Validator or equivalent thermal mapping systems
• Direct experience in commissioning and qualification of critical utility systems, critical process equipment and computer systems.
• Direct experience working in an aseptic formulation and fill manufacturing environment.
• Strong knowledge of industry standards for sterility assurance in an aseptic manufacturing environment
• Working knowledge of statistical concepts and tools