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Day Process Engineer

4 months ago

Atlanta, United States PSC Biotech Full time

Job Description 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 point 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. Day Process Engineer Overview: The Day Process Engineer is the Equipment SME for the process equipment within the Vaccine IPT(s) The Process Engineer will be responsible for providing engineering support to the Vaccine IPT(s) in relation to the process equipment. This includes trouble shooting, investigating and documenting process equipment issues that may have arisen on shift. The Day Process engineer will own all Quality and Safety investigations handed over from the shift. They will also own any resulting CAPAs relating to process equipment. They will identify and assist in the implement equipment process improvements and optimization opportunities. Requirements Requirements: · Process optimization: continually evaluate and optimize manufacturing processes to enhance efficiency, reduce waste, and minimize costs. Analyze data, collaborate with cross-functional teams, and identify areas for improvement to achieve operational excellence. · Troubleshooting and problem-solving: Play a critical role in identifying and resolving issues in manufacturing processes. Analyze data, conduct root cause analysis, and develop and implement solutions to improve process performance and resolve bottlenecks. · Process documentation: Responsible for creating and maintaining maintenance plans on SAP, and engineering standard operating procedures (SOPs), work instructions, and process flow diagrams. · Continuous improvement: actively participate in continuous improvement initiatives and lean manufacturing practices. Collaborate with cross-functional teams to implement process improvements, such as implementing automation, reducing cycle times, and enhancing product quality. · Quality control: work closely with quality teams to ensure that manufacturing processes comply with quality standards and regulations. QN and CAPA owner. Conduct audits with the quality team to identify opportunities for improvement. · Project management: Lead or participate in projects related to process improvement, new product introduction, cost reduction, or capacity expansion. Coordinate project activities, set timelines, allocate resources, and ensure successful project implementation. · EHS: Works closely with the EHS teams to ensure EHS compliance. Completes EHS investigation, CAPA owner and is Standard Owner for SN25 Hot Work. Continuous Improvements: · Identify opportunities for process improvements, cost reductions, and energy efficiency enhancements related to mechanical systems and equipment. Coaching and Training: · Develop an effective, focused, and strong team by understanding: their abilities and unique contribution. Provide your team with the tools and development opportunities to make them successful. Key Behaviours: Focus on Customers, Including Patients · Focus the team on delivering value for customers, including patients, by understanding and meeting their needs. · Collaborate · Actively listen and seek to understand differing perspectives from project team members; work together to achieve the common goals of the company. Act with Candor and Courage · Speak openly, honestly and with conviction; have the courage to take appropriate risks and make difficult decisions. · Make Rapid, Disciplined Decisions · Make timely decisions at the right level with the right data, document decisions and support them once made. Drive Results · Set clear performance standards; overcome obstacles; hold ourselves and others accountable for achieving results. Demonstrate Ethics & Integrity · Adhere to the highest standards of trustworthy and ethical behaviour in all interactions and hold others to the same standards; comply with all laws, policies and regulations; identify and address ethical issues without hesitation. · Build Talent: Build diverse talent with the capabilities necessary to succeed in commercial vaccine manufacture; inspire, reward and develop to ensure individuals reach their potential; make tough calls when necessary. Experience: · Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. manufacturing, quality, engineering, etc). · At least 10 years’ experience in the Pharmaceutical industry or a similar operating environment which includes significant leadership roles with experience in a front-line supervisory role in an operations environment. · Knowledge of and experience in applying Six Sigma and Lean methodologies. · Demonstrated leadership and change management skills with a continuous improvement focus. Skillset: · Proven track record of delivering high performance against a balanced scorecard through development and coaching of a team. · Demonstrated ability to fully realize change and improvement initiatives. · Demonstrated ability in holding team members accountable for results and managing performance. · Demonstrated leadership behaviours · Experience of moulding a culture to one of inclusion and continuous development for all employees. · Stakeholder management of multiple decision makers, corporate colleagues, cross-functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels. · Process and technology background: the successful candidate will fully understand how to drive process optimisation. Qualification: · Degree or 3rd level qualification (Science, Engineering). Masters preferred. · Desirable project management qualification such as Project Management Professional etc. · Desirable evidence of Continuous Professional Development. · Preference Lean Six Sigma Black Belt Reports to: · Engineering Maintenance Lead Requirements • Process optimization: continually evaluate and optimize manufacturing processes to enhance efficiency, reduce waste, and minimize costs. Analyze data, collaborate with cross-functional teams, and identify areas for improvement to achieve operational excellence. • Troubleshooting and problem-solving: Play a critical role in identifying and resolving issues in manufacturing processes. Analyze data, conduct root cause analysis, and develop and implement solutions to improve process performance and resolve bottlenecks.