Title:  Sr Mgr, Engineering

Job Summary

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.
• Improves manufacturing engineering and management job knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies.
• Develops strategic manufacturing operations plan by evaluating marketing and product objectives; calculating equipment, process, and labor capacity and requirements; determining tooling and maintenance objectives and requirements; developing layouts; establishing priorities.
• 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.
• Maintain ownership of assigned equipment, or business processes.
• Collaborate and interface with internal and external global teams and Subject Matter Experts (SMEs) as needed to maintain relationships and global process alignment.
• 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.
• Participates in Design for Manufacturing (DFM) reviews with internal teams. Reviews drawings, 3D models, and specifications to facilitate manufacturability.
• Improves cost effectiveness by studying operations; designing and conducting improvement studies.
• Provides manufacturing engineering information and reports by collecting, analyzing, and summarizing manufacturing engineering data and trends.

Additional Responsibilities

• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Proven ability to effectively prioritize and execute tasks in a high-pressure environment
• Must also be able to maintain confidentiality and resolve conflicts.
• 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.
• Able to comply with the company’s safety policy at all times
• Able to comply with the company’s quality policy at all times.

Education

• Bachelor's Degree in Engineering or a related field required or
• Master's Degree in Engineering or a related field preferred

Work Experience

• Minimum 10 years Experience in a technical engineering role or related areas including direct experience in equipment design, procurement, FAT, SAT, and IQ/OQ. required and
• experience in pharmaceutical/biotech manufacturing, or medical device manufacturing environment. required and
• Direct knowledge and experience in project management within a biopharmaceutical or pharmaceutical cGMP environment. preferred

Preferred Knowledge, Skills and Abilities

• Excellent written and verbal communication skills with all levels of employees. Must exhibit a positive and professional upbeat tone and manner.
• 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

License and Certifications

• Program and Project Management\Certified Project Management Professional (PMP)-PMI Upon Hire preferred and
• Manufacturing\Lean Six Sigma Black Belt within 1 Year required

Travel Requirements

Physical Requirements

Additional Requirements

• Comfortable working in a manufacturing environment.
• 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.