Principal Manufacturing Compliance Engineer

About the position

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Manufacturing Operations is responsible for supporting large scale mammalian cell culture and multi-stage large scale chromatography manufacturing operations as part of a 24/7 large-scale therapeutic protein or vaccine manufacturing facility. Operations’ main functions are leading deviation investigations and managing CAPA implementation, partnering with direct manufacturing staff for enhancing and improving the manufacturing instruction set, overseeing, and supporting manufacturing’s training program, and identifying and managing continuous improvement initiatives. Principal Manufacturing Compliance Engineer owns and ensures a robust investigations process, uses expert knowledge of compliance and GXP manufacturing processes to manage investigations, improvement initiatives, and major projects within manufacturing operations. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible.

Responsibilities

• Practice and promote safe work habits and adhere to Sanofi’s safety procedures and guidelines.
• Lead and perform investigations, CAPAs and Change Controls (CCRs) for on-time closure and supporting Annual Product Reviews.
• Provide guidance and direction to team to drive complex investigation close outs, determine root cause and implement appropriate Corrective and Preventative Action.
• Utilize manufacturing process knowledge and investigation skill sets to identify and resolve manufacturing issues, improve process operations, and affect positive change.
• Represent Manufacturing Compliance Engineer team on cross-functional teams involved in the design and implementation of new or updated quality systems in accordance with the corporate standards, regulatory standards, cGMP, and industry standards.
• Actively participate and provide input and feedback to cross functional teams to ensure alignment on investigations and identified corrective and preventative actions impact to department and site metrics.
• Maintain and report applicable department or organizational metrics.
• Routinely perform trend and statistical analysis as required to identify continuous improvement opportunities within manufacturing functional groups.
• Work to develop strategy and action plans for improving the system where opportunities are identified.
• Lead and actively participate in cross-functional continuous improvement projects with Manufacturing, Engineering, Validation, Quality Assurance, Quality Control, Facilities, Metrology, and Manufacturing Technical Services.
• Recognize and act on potential compliance issues and opportunities for process changes/improvement.
• Provide front room support during regulatory inspections.
• Represent investigation team during internal and external GxP audits.
• Partner with cross functional teams and team members, direct and indirect management chain to ensure timely completion of investigation, deviations and CAPA.
• Facilitate, collaborate, complete, and actively follow-up on investigations.
• Support investigation team to ensure site Key Performance Indicators (KPIs) are consistently met.
• Use experience and knowledge of manufacturing functional areas to propose continuous improvements to deliver efficiency gains.
• Assess customer needs and provide effective solutions through regular analysis of data and information reported from a broad variety of sources.
• Routinely assess progress made against Key Performance indicators to reach individual and team goals.
• Sensitive to the broader work environment and foster relationships with partners, experts from other functions and customers in order to achieve tactical objectives.
• Monitor Quality Systems (e.g., investigations and CAPAs) activities to ensure compliance with company and regulatory standards.
• Assist with Quality Management Review (QMR)/Quality Council.
• Support Corporate Compliance initiatives.

Requirements

• Bachelor's degree in Sciences, Technical, Engineering or Advanced degree with 8 years in a cGXP manufacturing environment or a Master’s degree in Sciences, Technical, Engineering or Advanced degree and 3 years of experience in cGXP manufacturing environment.
• Experience in troubleshooting, investigation, and root cause analysis in a cGMP environment.
• Proficiency with critical thinking and technical writing.
• Thorough knowledge and understanding of the technical and commercial aspects of pharmaceutical API products, Current Good Manufacturing Practices {part of GxP}, validation principles, and applicable regulations.
• Extensive experience with Quality Management Systems.
• Ability to learn and operate various enterprise systems including LIMS, SAP, OSI/PI, EMS, BMS.
• Knowledge of GXP regulations and guidance.
• Ability to effectively coach and train employees.
• Demonstrate high-level of communication for cross-functionally and across levels, including timely identification of potential sources of conflict and resolve independently or escalate to stakeholders promptly.
• Excellent verbal and written communication skills, with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups.
• Strong ability to balance the speed of delivering work with quality and shows commitment to make improvements in both aspects.
• Demonstrate a high degree of engagement and involvement in all job-related activities.
• Catalyst for selecting methods, techniques and evaluation criteria for obtaining results.
• Mentor junior members of team on technical topics.
• May potentially be a Qualified Trainer on investigation process.

Nice-to-haves

• Bachelor’s degree in Biology, Chemistry, Biochemistry, Chemical Engineering.
• Operations experience in one or more of the following areas: Quality Assurance, Quality Control, Manufacturing Technical Support, Facilities Engineering, or Automation.
• Keeps tasks (deviations, CAPA, or CCR) on schedule, tracks them carefully, and delivers results on time; seeks assistance to solve a problem quickly to adhere to on-time delivery.
• Experience with project management.
• Experience in supervisory teams.
• Ability to lead staff in absence of people manager.

Benefits

• High-quality healthcare.
• Prevention and wellness programs.
• At least 14 weeks’ gender-neutral parental leave.