What are the responsibilities and job description for the PROJECT MANAGER position at Fresenius Kabi USA, LLC?
Job SummaryThe Serialization Project Manager is responsible for planning and tracking projects related to serialization, packaging and labeling technologies. The incumbent conducts detailed planning on the basis of predefined project structures together with project and other participants. The planning also includes the description of target scenarios, definition of requirements and deliverables on project level. The project plan must be aligned with all relevant project members. The position is responsible for continuously monitoring the technical status and progress of the plan and support in FAT, SAT and testing. In case of deviations from project timelines or budgets, the Project Manager initiates appropriate activities in the respective teams to ensure the project plan will be met, follows up on those measures and reports them to leadership and other concerned persons (project control).
Salary Range: $130,000 - $150,000
* Position is eligible to participate in a bonus plan with a target of 10% of the base salary
* Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
* Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.Responsibilities
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, disabilities, or protected veteran status.
Salary Range: $130,000 - $150,000
* Position is eligible to participate in a bonus plan with a target of 10% of the base salary
* Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
* Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.Responsibilities
POSITION RESPONSIBILITIES
- Participation in planning, execution and supervision of the US Serialization, RFID and 2D data matrix on primary Programs
- Technical Expert for Level 2 3 (Mettler Toledo PCE or Wipotec OCS or Optel Vision)
- Local support during project, systems and equipment implementation
- Evaluation and technical assessment of proposed serialization/packaging solutions
- Training employees in Track&Trace
- Support Fresenius Kabi Organizations in connection with the US Serialization Program
- Compilation, maintenance and further development of documents (Program Manual, Guidelines, gWIs, SOPs)
- Communication and coordination with external entities
- Project management to carry out the main tasks
- Coordinates resources to effectively complete projects on time, within budget and within technical scope.
- Establishes necessary priority deadlines and accountability for self and others / tracking and presenting status of the project.
- Ensures that projects are in compliance with FDA and regulatory requirements.
- Coordinates project team with others (e.g. leadership team, ext. resources, etc.), ensuring effective working relationships and partnerships between the groups.
- Leads teams of engineers, validation personnel, maintenance personnel, quality personnel, and operations personnel to specify, develop, and implement serialization solutions for existing and new fully automated manufacturing equipment.
- Initiates change control, risk assessments, work orders, SOP's, AOF's, purchase orders, and other required paperwork to maintain compliance with company policies.
- Drives installation and/or modifications of serialization equipment, including vendor selection, procurement of equipment or services, scheduling, vendor coordination, set-up, start-up, troubleshooting, de-bugging, and training.
- Designs, prototypes, and implements serialization and control improvements to existing production equipment to improve efficiencies.
- Develops Serialization Engineering Standards, Procedures and Technical Specifications.
Requirements
- Bachelor's degree required. Preferably in Electrical or Computer Engineering (or similar relevant discipline)
- 5-8 years of experience in Serialization/packaging projects in pharmaceutical industry or related
- In-depth technological knowledge in serialization IT systems
- Good technological knowledge of packaging equipment including but not limited tovial/syringe labelers, Dividella tray packer or Pester case packer/palletizer
- Proficient in the use of MS-Project and/or Smartsheet to manage complex projects
- Knowledge of project management methods, techniques and tools
- Excellent communication and conflict management skills
- Proficiency with SAP ERP/R3 is preferred
- Proficiency with TraceLink Cloud Solution
- Familiar with regulated industry, cGMP, GAMP, 21CFR Part 11 and other industry best practices
- Able to travel 20-25% to additional site locations
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness 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.
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, disabilities, or protected veteran status.
Salary : $130,000 - $150,000
