Engineering Manager

Global Life Science Hub is partnered with a niche, specialist biopharmaceutical company offering next-generation drug delivery technologies and an advanced pipeline of oral and biosimilar drugs. With 2 FDA approvals and new in-house manufacturing capabilities, they are primed to triple their production into 2025 to improve patient outcomes through innovative drug delivery technologies and therapeutic solutions.

As next phase of growth, we are now seeking an Engineering Manager to oversee and spearhead the several departments within the Engineering sector.

Responsibilities:

• Adheres to all organizational policies and standards.
• Oversees and directs the company's developmental engineering functions, including:
• Establishing reliability standards for design and production materials and techniques.
• Supervising the activities related to mechanical systems and equipment operations.
• Leading research or technical design efforts for developing, modifying, and evaluating electronic parts, components, or integrated circuitry.
• Ensures all processes eliminate any health or safety risks.
• Develops and maintains the Engineering Change System.
• Manages the current and future footprint of the facility based on business needs.
• Sets preventative maintenance standards for new equipment.
• Plans, directs, and documents periodic preventative maintenance and equipment analysis.
• Keeps drawings and specifications for all equipment updated.
• Researches and implements cost-effective upgrades to equipment and facilities.
• Oversees the Lean Manufacturing methodology for new, current, or transferred programs.
• Recommends and initiates modifications or replacements of equipment that do not meet operational standards.
• Participates in the Health, Safety, and Environmental program, adhering to all relevant policies, procedures, and work instructions.
• Stays current with the latest in control technology and safe work practices.
• Manages and updates all equipment in various laboratories (ENG, MFG, QC, Micro).
• Conducts feasibility studies to ensure designs function as intended.
• Selects, develops, and evaluates personnel for efficient function operation.
• Receives assignments as objectives and determines resource allocation to meet schedules and goals.
• Provides guidance within the framework of established company policies.
• Recommends policy changes and establishes procedures.
• Frequently collaborates with management and other departments to resolve issues and lead team efforts.
• Manages the Engineering department's activities, ensuring responsible results, including costs, methods, and staffing.
• Fulfills additional duties as requested by management.
• Ensures compliance with FDA and EU regulations.
• Tracks and successfully completes all routine and non-routine activities.
• Conducts GAP analysis and provides recommendations for existing qualifications.
• Thrives in a fast-paced, team-oriented environment.
• Demonstrates technical problem-solving abilities, manages multiple priorities, provides logical and analytical reasoning, technical writing skills, and self-training.
• Manages engineering projects from design through qualification, depending on experience and skill set.

Experience/Qualifications:

• Bachelor’s or Master’s degree in a related Engineering field.
• Minimum of 3 years in a biotech, pharmaceutical, or medical device setting