Engineering Manager

Essential Duties

• Comply with all company policies and standards.
• Plan, direct, and implement the organization's developmental engineering functions, which may include reliability standards pertaining to materials and techniques used in design and production, mechanical systems and equipment activities, and research and technical design activities responsible for designing, developing, modifying, and evaluating electronic parts, components, integrated circuitry, and other hardware systems.
• Ensure all processes minimize health and safety risks.
• Develop and maintain the Engineering Change System.
• Maintain responsibility for the plant's current footprint and understand future footprint requirements based on business needs.
• Determine preventive maintenance standards for new equipment.
• Plan, direct, document, and analyze periodic preventive maintenance activities.
• Maintain and update drawings and specifications for all equipment.
• Research and implement cost-effective upgrades to equipment and facilities.
• Manage Lean Manufacturing methodologies for current, new, and transferred programs.
• Recommend and initiate modifications or replacement of equipment that fails to meet operating standards.
• Participate in the Health, Safety, and Environmental (HSE) program by following all applicable policies, procedures, and work instructions, including safety rules, safety observation audits, regulatory compliance, environmental awareness initiatives, audits, and continuous improvement activities.
• Keep current with advances in control technology and safe work practices.
• Understand, manage, and maintain awareness of all equipment within Engineering, Manufacturing, Quality Control, and Microbiology laboratories.
• Manage feasibility studies to determine whether designs are capable of functioning as intended.
• Select, develop, and evaluate personnel to ensure the efficient operation of the engineering function. Provide guidance to subordinates within established company policies.
• Receive assignments in the form of objectives and determine how to effectively utilize resources to meet schedules and goals.
• Recommend changes to policies and establish operating procedures as needed.
• Frequently interact with management and employees across departments to resolve issues and support business objectives.
• Ensure compliance with FDA and EU regulations.
• Perform gap analyses and provide recommendations for existing qualifications.
• Demonstrate the ability to work effectively in a fast-paced, team-oriented environment.
• Apply technical problem-solving skills, manage multiple priorities, utilize logical and analytical reasoning, demonstrate technical writing proficiency, and maintain the ability to self-train.
• Manage engineering projects from design through qualification, depending on experience and skill set.
• Perform other duties as assigned by management.

Qualifications

Education: Must have a Bachelor of Science degree in Engineering or related field. Masters of Science in Engineering or related field is a plus.

Experience: Must have at least 3 years of experience in a biotech, pharmaceutical or medical device setting. Project management is a plus. Must have at least 3 years of supervisory experience in biotech, pharmaceutical or medical device setting. Able to work in a fast-paced environment. Technical problem solving, handling multiple priorities, performing well under stressful situations, thinking fast, logical, and mathematical reasoning, technical reading interpretation and self-training.

Occasional trips for equipment FATs at vendor sites, or other business needs (lasting up to 2 weeks at a time). Potential for international travel.