Associate Director, Automation Engineer

Job Description

Primary Responsibilities:

• Automation and equipment performance to ensure robust operation while maintaining compliance with all current regulatory expectations. 

• Receives assignments, direction, and technical guidance from leadership and/or Pharm Sciences colleagues. 

• Recommends and executes programs of value to the Company which lead to availability of Clinical Supplies and Development Batches to meet Clinical Development Program requirements. 

• Partners with Quality, Operations, Technology, and Financial to value these efforts to develop cost standards for new or modified processes. 

•  Initiates and provides resources for technical support of capital projects in area of process, equipment, and/or automation responsibility, culminating in directing the coordination of startup and qualification efforts. 

•  Solicits and shares best practices with peers.

• Exercises complete objectivity in reporting findings, is seen as highly cooperative and responsive in dealings with others inside and outside of his/her group and exercises utmost care in ensuring personal safety and the safety of others.

•  Knowledgeable of cGMP’s, financial principles, QA policies, safety guidelines, data integrity guidelines, engineering standards, and regulatory issues.  Provides technical, project management and system leadership.

 

Education Minimum Requirement: 

• BS in Engineering Science, or Information Systems, plus a minimum of 5 years of related technical support or manufacturing automation experience or acceptable related experience.

 

Required Experience and Skills: 

• Strong familiarity with Quality, cGMP, Safety & Environmental Policies and Procedures.

• Demonstrated technical proficiency, leadership skills, and leadership skills necessary to work within a high-performance group of technical professionals.

• Troubleshooting ability (mechanical/electrical/automation) and capital project (support). 

• Ability to flexibly adapt to flow to the work across both Quality and Facility aspects to support the business.  

• Strong organizational skills. 

• Effective communication

System administration and management of the following automated systems;

• Programmable Logic Controllers

• Supervisory Control And Data Acquisition systems

• Distributed Control Systems

• Batch Operations (S88/S95)

• Manufacturing Execution Systems

• Information Technology

• OEM equipment.

Preferred Experience and Skills: 

• The candidate should be able to work independently and lead or facilitate tasks successfully.

• Strong knowledge of business impacts and prioritization of technical initiatives.

• Ability to manage directly or indirectly via project.

Required Skills:

Accountability, Accountability, Adaptability, Automation, Capital Projects, Chemical Engineering, Clinical Development, Communication, Communication Management, Customer-Focused, Data-Driven Decision Making, Drug Product Development, Estimation and Planning, General Safety, Manufacturing Quality Control, Mechanical Troubleshooting, Pharmaceutical Process Development, Process Control Automation, Process Optimization, Product Formulation, Project Management, Quality Control Management, Regulatory Compliance, Regulatory Issues, Safety Compliance {+ 5 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a fede