What are the responsibilities and job description for the DIRECTOR, MANUFACTURING IT position at Fresenius Kabi?
Job Summary
Responsible for the Manufacturing IT (MIT) and eBR (Electronic Batch Record) Departments at the Melrose Park manufacturing site. Manufacturing IT responsibilities include developing and designing strategic long term manufacturing IT plans, directing the capital budget process, directing and managing MIT projects, managing MIT and eBR staff, systems upgrades, technical troubleshooting and 24/7 support. eBR responsibilities include development, design, implementation, and support of eBR systems at MP, directing and managing eBR projects and eBR staff at MP, systems upgrades, technical troubleshooting and 24/7 support. Partnering with BU MIT staff on key initiatives including providing recommendations to ensure technical infrastructure aligns with the overall business objectives and complies with all regulatory agencies.
Responsibilities
- Salary Range: $160,000 - $200,000
- Position is eligible to participate in a bonus plan with a target of 16% of the base salary
- Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
POSITION RESPONSIBILITIES
- Manages full coordination of MIT and eBR staffs, ensuring effective working relationships and partnerships between the groups.
- Position will be responsible for leading the engineering team that is working with our internal IT systems to fully automate the batch record process into an electronic batch record which will automate the current paper batch record process.
- Manages resources to effectively complete projects on time and within budget
- Directly responsible for budget control of all capital projects. This includes preparation, review and presentation to the ISC along with generation of Appropriation of Funds requests.
- Analyzes production or process problems. Initiates and implements project definitions and plans to effectively resolve and implement solutions.
- Develops Engineering Standards, Procedures and Technical Specifications
- Ensures timely and within budget completion of the projects in the Manufacturing IT and eBR areas of responsibility.
- Provides technical direction and assistance to staff and plant
- Reviews and approves Change Requests, Procedures and Validation Protocols
- Effectively leads and interacts with Production, Quality, Maintenance and Validation to achieve project goals.
- Creates and implements comprehensive training programs for staff to ensure continuous career growth, development and cross training.
- Analyzes production or processing problems and initiates project definitions to resolve them.
- Assures that projects are in compliance with State, Federal and local codes which encompass EPA, FDA, OSHA, and hazardous waste-related issues.
- Maintains awareness of current pharmaceutical manufacturing needs, requirements and … standards. Initiates programs/projects to achieve state of the art pharmaceutical manufacturing status, continuous improvement of production operations and facility compliance.
- Assures that all MIT systems in the facility compliant and in top operational condition by maintaining appropriate preventative/predictive maintenance program.
As part of Top Management, you have the overall responsibility and accountability for all aspects of the Health, Safety, Environment, Energy, and Quality Management Systems, including the following:
- taking overall responsibility and accountability for the prevention of work-related injuries and ill health, the protection of the environment, as well as the provision of safe, harmless, and healthy workplaces,
- ensuring that the Health, Safety, Environment, Energy, and Quality Management Systems’ policies and related objectives are established and are compatible with the strategic direction of the organization
POSITION REQUIREMENTS
- Bachelor’s degree in engineering or equivalent field required; Master’s degree preferred.
- Minimum of 10 years project management experience with a proven record of achievement in a regulated manufacturing environment, preferably pharmaceutical.
- Minimum of 5 years’ experience managing direct reports.
- Experience managing projects in excess of $1MM
- Previous experience supervising a Maintenance, Metrology and Engineering Department.
- Demonstrated leadership and team building skills
- Excellent oral and written communications skills
- Knowledge of high-speed filling and packaging equipment
- Knowledge of Critical Utilities (WFI, Clean Steam, OFCA, HVAC)
- Six Sigma training/experience desirable
- Operations and Maintenance experience desirable
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
Salary : $160,000 - $200,000
