MS&T Process Engineer -Hybrid

Job Description

About PSC Biotech

Who are we?

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.

Overview :

The MS&T Process Engineer delivers a range of technical support to the Drug Substance Business : leading technical investigations within the Integrated Process Team, supporting significant projects across the site, supporting design, construction and qualification of upstream & downstream equipment (when applicable), NPI / technology transfer and commercialization . The MS&T Process Engineer ensures that MS&T team objectives are effectively achieved, consistent with the requirements to ensure compliance, safety and reliable supply to our customers, while creating an inclusive culture that energizes a Safety First, Quality Always, continuous improvement mindset.

Requirements

Primary Responsibilities :

• Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
• Design / Author / Review / Approve / Execute qualification documentation in line with the standard process.
• Leads experimental design of studies, execution, data analysis and interpretation. Authors and reviews batch documentation, regulatory and technical documentation
• Interpret trends observed in commercial process monitoring (e.g., proactive process analysis (PPA), continued process verification (CPV), statistical process control (SPC) multivariate analyses (MVDA)), and for further technical investigations and process changes that seek to drive improvements to yield and / or robustness.
• Support the execution of development and PPQ batches, change control management and implementation
• Lead multidisciplinary teams (manufacturing science and technology, quality, analytics, regulatory) for process improvement and troubleshooting with end-to-end product focus through Lean Six Sigma methodologies.
• Lead and facilitate investigations, ensuring effective Root Cause Analysis and CAPAs. Participate in audits and inspections.
• Lead and / or support various site initiatives to improve compliance status and overall operational efficiency of the site. Serve as a key member during internal audits and external inspections / audits
• Lead and support various MS&T organizational initiatives as needed (examples include safety, financial forecasting, work standardization, etc).
• Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.

Qualification and Experience :

General competencies :

Technical :

Minimum Education / Experience :

Requirements

Bring energy, knowledge, innovation and leadership to carry out the following : Lead SAP master data build and data approval activities including hypercare, sustainment materials build, BOMs and Recipes. Participate daily on cross-functional teams collaboratively and actively to address compliance issues and achieve project milestones. Support implementation and training for site Quality Systems and site GMP readiness activities. Support creation, maintenance and continuous improvement of Quality Management Systems (QMS) and associated documentation. Provide QA review and approval of Change Controls, Deviations / CAPAs, SOPS and related documentation for compliance to GMP and site requirements at the start-up facility. Support other QA colleagues, as required. Work collaboratively to foster strong relationships with management and colleagues and to drive a safe and compliant culture. Support gathering of site metrics Ensure the escalation of risks to management in a timely manner.