Title:  Manager, Engineering

Job Summary

The Manufacturing Engineering Manager is part of the Site Leadership Team and the candidate will have significant experience in process engineering, project execution, and leadership of engineering teams. The manager will be accountable for implementing sustainable processes and will be responsible for measuring and reporting results to ensure qualified processes reach and sustain consistent design characteristics and production levels. This position must provide technical expertise and lead a team of manufacturing and project engineers in the planning/execution of tasks on multiple projects within budget and schedule constraints. This position must work with other engineering disciplines and interface with global colleagues. This role also includes presenting a professional appearance as well as presenting a professional attitude and representing the company core values. The engineering manager will be critical in supporting and leading a start up team in a medical device manufacturing environment.  They will have the opportunity to be part of a dynamic business and work in an environment that celebrates learning, problem solving, and continuous improvment. 

Essential Duties and Responsibilities

• Lead the site Manufacturing/Project Engineering Department to ensure full alignment with the company and site strategies which includes significant growth utilizing new and existing technologies.
• Manage and coordinate plant and capital projects, properly document work, and maintain history of projects in appropriate project files.
• Propose and lead equipment and process improvement initiatives to improve operating performance
• Create strategic plans to eliminate waste within the business by utilizing lean process, best practices and enterprise resource management.
• Provide engineering guidance to assure plant, machinery, and processes are optimized. Set up or participates in continuous improvement teams related to establishing a process or process improvement.
• Collaborate and interface with internal and external global teams and Subject Matter Experts (SMEs) as needed to maintain relationships and global process alignment.
• Maintain ownership of assigned equipment, or business processes.
• Lead/support validation activities including equipment validation and process validation. Improve processes and procedures to manufacture a quality product at a minimum cost. Provide technical expertise to other plant personnel.
• Research and analyze data such a vendor design proposal, specifications, and manuals to determine feasibility of design or application.
• Assist in installation of new products, tooling and related processes; investigate tooling and process problems; make new product/process recommendations.
• Provides engineering assistance to ensure plant, machinery, tooling and processes are at optimum.
• Continuous coaching of team members and assist with developing/implementing team member growth plans.

Additional Responsibilities

As an early member of our newest West site, you will thrive if you can:  

• Bring a positive, can-do attitude every day as we build and grow together. 
• Contribute to ramping up a state-of-the-art manufacturing facility from the ground up. 
• Embrace change and innovation as we launch new operations at record speed. 
• Work hard, stay flexible, and support your teammates to achieve shared goals. 
• Take pride in producing high-quality products that improve patient lives worldwide. 
• Live West’s core values of integrity, teamwork, and accountability in everything you do. 
• Be part of a culture that celebrates learning, problem-solving, and continuous improvement. 
• Show initiative and ownership while helping shape a safe, efficient, and high-performing workplace. 
• Grow your career and skillset in a dynamic, innovative environment where your contributions truly matter. 
• Work independently and take initiative in areas that may not be formally assigned to you. 
• Thrive in ambiguity and see change as an opportunity rather than a challenge. 
• Work in an evolving fast-paced environment where priorities shift, and new opportunities emerge regularly.

Education

• Bachelor's Degree BS in Engineering or a related field with 8 years of experience in a technical engineering role or related areas including direct experience in equipment design, procurement, FAT, SAT, and IQ/OQ. required

Work Experience

• Minimum 8 years Minimum 8 years of experience in pharmaceutical/biotech manufacturing, or medical device manufacturing environment. required

Preferred Knowledge, Skills and Abilities

• Direct knowledge and experience in project management within a biopharmaceutical or pharmaceutical cGMP environment.
• Excellent written and verbal communication skills with all levels of employees. Must exhibit a positive and professional upbeat tone and manner.
• Proficient in technical writing
• Experince in equipment and process validation to pharmaceutical standards
• Risk management (FMEA)
• Experience in secondary packaging for pharmaceuticals
• High proficiency for problem solving in teams and as an individual contributor. Exceptional verbal and technical writing skills; ability to provide focus and clarity. Independently motivated, detail oriented and good problem-solving ability.
• Excellent organizational skills with the ability to multi-task in an extremely fast-paced environment with changing priorities.
• Knowledge of Computer Aid Design such as AutoCAD or Solid Works.
• Strong essential skills including high emotional intelligence
• High sense for the business; strong business acumen
• Strong coordination and Project Management skills
• Engages others, builds relationships, and creates networks outside team. Checks in with different people to understand the bigger picture.
• Ability to perform root cause analysis and corrective action solutions. Follows through on actions.
• Is curious, agile, engages in new experiences and looks for different perspectives
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Able to comply with the company’s safety policy at all times
• Able to comply with the company’s quality policy at all times.
• At least 3 years of supervisory or leadership experience.
• Sterilization or Aseptic processing experience.

License and Certifications

• Program and Project Management\Certified Project Management Professional (PMP)-PMI Upon Hire preferred
• Manufacturing\Lean Six Sigma Black Belt Upon Hire preferred

Travel Requirements

Physical Requirements

Additional Requirements

• Proven ability to effectively prioritize and execute tasks in a high-pressure environment
• Must also be able to maintain confidentiality and resolve conflicts.
• Comfortable working in a manufacturing environment.
• Previous experience in start up or entrepreneurial environments where adapatablility is preferred
• Ideal candidate will see ambuguity as an opportunity rether than a challenge
• Specific vision abilities may be needed by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
• Make independent and sound judgments.
• Multitask, work under time constraints, problem solve, and prioritize.
• Excellent communicator with ability to maintain confidentiality and resolve conflicts and ambiguity.
• Use written and verbal communication skills effectively.
• Read and interpret data, information and documents to analyze and solve problems.
• Learn and apply new information and new skills.