Work for a global healthcare leader. Eclaro is looking for a Project Manager - Engineering for our client in Collegeville, PA.
Eclaro’s client is world-renowned for providing innovative healthcare solutions and for its commitment to improving the health and well-being of people from all walks of life. If you’re up to the challenge, then take a chance at this rewarding opportunity!
The Project Manager will provide leadership support to the PGS network and will ensure that the plant network strategy focusing on the zero defects transfers' process is applied consistently in the areas of risk management, knowledge management and process understanding as part of the Knowledge and Process Excellence (KPEx) function in Global Technology Services (GTS).
This position requires strong leadership, facilitation, and interpersonal skills and effective written and verbal communication skills with GTS subject matter experts and site technical colleagues. A comprehensive understanding of the principles of quality risk management, risk assessment processes, and Pharmaceutical knowledge management practices is required
- Assure consistent execution of established tools to enable colleagues across PGS to capture, retain and leverage process understanding for both internal sites and CMOs
- Build the capabilities of the colleagues in the network by developing and delivering targeted training. The training will be delivered using existing content in accordance with needs as established across the PGS network.
- Provide direct hands-on support for risk assessments and process understanding plans supporting an average of 300+ products transferring between manufacturing sites across the Pharmaceutical network.
- Will have established the ability to manage own time to meet personal objectives, forecast resource requirements for projects across the KPEx department, and have a demonstrated competency to manage complex projects.
- Work with the site subject matter experts to generate and/or facilitate process flow diagrams in Pharma Investigator, cause and effect matrices and failure mode and effect analysis templates.
- Facilitate risk assessments to support zero defects transfers
- Lead plant network strategy project teams to secure and organize all process knowledge documentation in the process understanding plan format; make decisions that require development of new options as required.
- Work with the project teams to facilitate process robustness assessments.
- Work with project teams to facilitate API-DP risk assessments
- Provide training and coaching in effective use of the tools as needed, including (PI, PUP, ZDT, PACT, GTI etc.,)
- Apply technical knowledge to troubleshoot and maintain knowledge and risk management data while operating in diverse BT systems.
- Develop and deliver training materials for all process tools and ensure that all training materials undergo continuous improvement based on customer feedback.
- Take appropriate risk to advance new moderately complex concepts and methodologies that advance risk and knowledge management principles.
- Support the PDC for GTI assessment for product transfers
- Practical experience in facilitating and conducting risk assessments strongly preferred.
- Excellent project management capabilities and communication skills throughout all levels of the organization is required.
- Direct experience effectively troubleshooting and supporting site colleagues with Knowledge and Process Excellence systems and tools strongly preferred.
- Demonstrated capability to take informal leadership role in working team environment.
- Degree in a science and technology discipline required.
- 3-5 years' in the biopharmaceutical industry preferred.
- Minimum of 2 years' experience working directly with Pharmaceutical sites preferred.
- Indirect matrix leadership of project activities
Please email Pat Bandiwan at Pat.Bandiwan@eclaro.com.
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.