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Project Engineer
4 months ago
About PSC Biotech
Who we are?
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.
‘Take your Career to a new Level’
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling points which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.
Employee Value Proposition
Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.
Role Description:
- We currently have exciting openings for a Project Engineer within our Site Engineering Department at our Client Site.
- In this role, you will report to the Utilities lead and be responsible for leading and managing multiple Technical Engineering projects.
- Your responsibilities will include overseeing the entire project lifecycle, from scope development and design to construction, installation, qualification, and handover to operations.
- These projects will primarily focus on Utility improvements, as well as Reliability centred upgrades, while providing general support to the Engineering operations group.
- The ideal candidate for this position will have prior project engineering experience, preferably in a manufacturing environment, with a strong preference for experience in a GMP Setting and Utilities Project experience.
Requirements
Responsibilities include:
- Take charge of multiple projects, overseeing their entire lifecycle from scope development, design, build/installation, and qualification to the handover to operations for key Engineering projects.
- Develop project scope, cost estimates, and delivery schedules in collaboration with the Site Engineering team and system SME’s.
- Collaborate closely with cross-functional teams to identify and establish improvement projects as the site scales up towards full commercial operation.
- Drive and support continuous improvement initiatives by actively participating in projects, conducting system failure investigations, contributing to investigation reports, executing, and developing change control processes, and taking part in Kaizen events when appropriate.
- Serve as a liaison between global engineering services, utilities, and specialist vendors to ensure the timely and successful delivery of projects, meeting the business's requirements.
- Ensure compliance with Global Policies, Procedures, and Guidelines, as well as regulatory requirements, while adhering to current Good Manufacturing Practices (cGMP) in daily activities and job functions. Accountable for completing relevant documentation, conducting risk assessments, closing out corrective actions, participating in audits and inspections, and proactively identifying compliance issues.
- Collaborate with various stakeholders to promote a safe and compliant culture, including company network groups, third parties, vendors, quality teams, donor sites, Supply Chain, and the Integrated Process Team (IPT).
- Deliver presentations and provide progress reports on projects to stakeholders as necessary.
- Manage vendors working on-site, ensuring their compliance with safety protocols, and permitting requirements for all activities conducted on-site.
- May be assigned additional duties as needed.
Experience, Knowledge & Skills:
- Extensive experience in a similar role, preferably with a background in the GMP pharmaceutical industry, where you have operated as a senior professional and made significant contributions to the business.
- Demonstrated experience in the Utilities area within a manufacturing environment, with a successful track record of delivering engineering projects.
- Equipment experience: e.g., Plant steam boilers, CTU’s, freezers, WFI, Clean steam, compressed air, HVAC, fume hoods, BSC’s, F-gas regulations.
- Knowledge of regulatory and code requirements in accordance with Irish, European, and International Codes, Standards, and Practices.
- Strong skills in writing reports, developing standards, and creating policies.
- Proficiency in Microsoft Office and relevant computer applications related to the job.
- Desired experience in Lean Six Sigma Methodology to drive process improvement initiatives.
- Possess a strong commitment to safety and prioritize a safety culture.
- Proven track record in project management and implementing change within a commercial site.
Qualifications & Education:
- Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or Other Technical discipline
- Green Belt preferable.
#LI-XA1
Requirements
Responsibilities include: Take charge of multiple projects, overseeing their entire lifecycle from scope development, design, build/installation, and qualification to the handover to operations for key Engineering projects. Develop project scope, cost estimates, and delivery schedules in collaboration with the Site Engineering team and system SME’s. Collaborate closely with cross-functional teams to identify and establish improvement projects as the site scales up towards full commercial operation. Drive and support continuous improvement initiatives by actively participating in projects, conducting system failure investigations, contributing to investigation reports, executing, and developing change control processes, and taking part in Kaizen events when appropriate. Serve as a liaison between global engineering services, utilities, and specialist vendors to ensure the timely and successful delivery of projects, meeting the business's requirements. Ensure compliance with Global Policies, Procedures, and Guidelines, as well as regulatory requirements, while adhering to current Good Manufacturing Practices (cGMP) in daily activities and job functions. Accountable for completing relevant documentation, conducting risk assessments, closing out corrective actions, participating in audits and inspections, and proactively identifying compliance issues. Collaborate with various stakeholders to promote a safe and compliant culture, including company network groups, third parties, vendors, quality teams, donor sites, Supply Chain, and the Integrated Process Team (IPT). Deliver presentations and provide progress reports on projects to stakeholders as necessary. Manage vendors working on-site, ensuring their compliance with safety protocols, and permitting requirements for all activities conducted on-site. May be assigned additional duties as needed. Experience, Knowledge & Skills: Extensive experience in a similar role, preferably with a background in the GMP pharmaceutical industry, where you have operated as a senior professional and made significant contributions to the business. Demonstrated experience in the Utilities area within a manufacturing environment, with a successful track record of delivering engineering projects. Equipment experience: e.g., Plant steam boilers, CTU’s, freezers, WFI, Clean steam, compressed air, HVAC, fume hoods, BSC’s, F-gas regulations. Knowledge of regulatory and code requirements in accordance with Irish, European, and International Codes, Standards, and Practices. Strong skills in writing reports, developing standards, and creating policies. Proficiency in Microsoft Office and relevant computer applications related to the job. Desired experience in Lean Six Sigma Methodology to drive process improvement initiatives. Possess a strong commitment to safety and prioritize a safety culture. Proven track record in project management and implementing change within a commercial site. Qualifications & Education: Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or Other Technical discipline Green Belt preferable. #LI-XA1
