- Title: Senior Project Engineer
- Code: RCI-8853
- Location: Warren New Jersey (NJ) 07059
- Posted Date: 12/02/2019
- Duration: 12 Months
In the position of Senior Project Engineer, the incumbent will support the Equipment Commissioning and Qualification (ECQ) department to achieve its business objectives. The Senior Project Engineer will create and manage schedules and control scope and budget of various projects including but not limited to: installation, qualification, maintenance or relocation or laboratory equipment. Through this work, the incumbent will support the successful operation of facility, laboratory and business functions at the Warren site through interaction with internal customers and external service providers. The incumbent identifies issues or unmet needs and initiates projects or programs to address them. Using solid analytical skills, the incumbent is able to recognize problems of moderate scope and complexity, and independently develop potential solutions and courses of action. This individual represents ECQ on multi-disciplinary and cross-functional teams and uses established relationships to influence and lead teams and stakeholders with fact-based, business value knowledge.
- Serve as a member of sub-teams, tracking timeline elements to ensure that functional deliverables are completed on time and according to relevant quality standards
- Create and manage project plan to achieve goals set for the project according to timeline and budget
- Plan and track scheduled project timelines and milestones using appropriate tools
- Manage project within approved budget
- Proactively identify program risks and work with the team and team leader to develop contingency plans
- Develop critical path analyses to understand risks and opportunities within project timelines
- Responsible for the preparation of routine status reports and communicate project health to stakeholders
- Promote a culture of collaboration, cooperation, execution excellence, effective communication, and cross-functional problem-solving to enable a high-performing team
- Ensure quality and compliance throughout the project life cycle
- Develop relationships with project stakeholders, contractors and customers
- Initiates, manages and leads cross-functional/cross-site projects of medium to advanced scope and complexity
- Manages laboratory systems implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area
- Promotes and provides excellent customer service and support
- Maintains a positive relationship with all the members of the Equipment Commissioning and Qualification department and site customers while promoting a positive team environment
- Promotes and maintains compliance with corporate, safety and regulatory policies
- Maintains all required Corporate, Facilities and EHS training as required
- BS degree in Engineering, Biology, Chemistry, Computer Science, or equivalent
- 10 years of combined experience in FDA-regulated GMP environment
- Minimum 3 years of Project Management Experience required within a pharmaceutical environment
- PMP certification Preferred
- Ability to interact effectively with laboratory personnel, QA, Engineering and Facilities groups
- Maintains a high level of multi-tasking ability in conjunction with proven organizational skills. Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously
- Highly proficient computer skills in Microsoft Office Suite – Word, Excel, PowerPoint, Project and Outlook. Innate ability to learn new software, such as corporate intranet and enterprise business.
- Strong written and excellent verbal communication skills. Highly proficient at writing well-formulated emails, notifications, and reports. Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task. Strong experience with technical writing and document development / generation.
- Excellent interpersonal skills with experience dealing with a diverse workforce.
- Ability to analyze situations and develop solutions. Modifies approaches and procedures to issues as they arise.
- Familiarity with FDA and EU compliance regulations
- Technical / Professional Knowledge
- Problem Solving / Troubleshooting
- Project Management
- Action Oriented
- Attention to Detail
- Building Relationships
Physical / Mental Demands:
* Occasional stooping, bending, stretching , pushing, pulling, reaching and/or lifting up to 20 lb
* Ability to sit, stand, walk and move within workspace for extended periods
* Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing and pulling
* Ability to work extra hours on limited occasions in order to meet deadlines
* Environment may include working in office or in a laboratory / manufacturing area.
* Ability to work safely in an environment with hazardous, radioactive, and infectious materials and waste.
* Ability to work safely when working alone, or working with others.