Operations Compliance Engineer

Role Summary

Operations Compliance Engineer.

Responsibilities

• Practices and promotes safe work habits and adheres to Sanofi‚Äôs safety procedures and guidelines.
• Manages cross functional team to drive complex investigation close outs, determine root cause and implement appropriate Corrective and Preventative Action.
• Utilizes GMP process knowledge and investigation skill sets to identify and resolve issues, improve process operations and affect positive change.
• Conducts complex document revisions and /or document management including batch production records, operations procedures, and cross functional procedures.
• Works with APU to develop and maintain training materials and curricula on process operations, theory and compliance.
• Leads cross-functional continuous improvement teams with Engineering, Validation, Quality Assurance, Quality Control, Facilities, Metrology, Materials Operations and Label and Pack.
• Works independently with minimal supervision and direction.
• Participates in determining objectives of assignment.
• Performs work that consistently requires independent decision making and the exercise of independent judgement and discretion.
• Effectively utilizes Microsoft office applications.
• Creates and presents trending and metrics reports.
• Understands concepts and applications of specialized or functional area, uses independent thought, analytical ability to achieve objectives that can impact the performance of standard resources that have been allocated through a plan or a budget.
• Compiles facts and diagnostics from a broad variety of sources (other functions/ internal stakeholders, customers, suppliers, regulators ...) to monitor the level of satisfaction or compliance associated with the delivery of products or services.
• Coordinates with others via teamwork and may provide technical or behavioral expertise and guidance to deliver results.
• Awareness of objectives of other functions and reacts quickly to recommend and promote efficient solutions or alternatives of complex issues.
• Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs.

Qualifications

• Education / Experience: High school diploma / GED with minimum 7 years experience (or) Bachelor‚Äôs degree and minimum 3 years experience working in a Bio-Pharma regulated cGMP environment.
• Bachelor‚Äôs degree in Biology, Chemistry, Biochemistry or Chemical Engineering
• Knowledge of GXP regulations and guidance.
• Minimum of 2 years experience with deviation management systems
• Excellent critical thinking and technical writing
• Excellent written and oral English language skills.
• Proficient with change control requests, CAPAs and deviation quality systems
• Proficient in critical thinking and technical writing
• Experience leading cross functional teams and facilitating team meetings.
• Ability to influence in a cross-functional environment.
• Experience authoring and reviewing standard operating procedures, on-the-job-trainings and other controlled documents.
• Proficient in balancing the speed of delivering work with quality and shows commitment to make improvements in both aspects
• Effectively tracks tasks related to deviations, CAPAs, or CCRs to ensure on-time adherence, and delivers results on time.
• Ability to work independently with minimal supervision to problem solve efficiently adhering to on-time delivery.
• Experience with project management.
• Experience with Veeva Vault.
• Experience in troubleshooting, investigation and root cause analysis in a GXP environment.
• Operations experience in one or more of the following areas: Quality Assurance, Quality Control, Manufacturing Technical Support, Facilities Engineering, Materials Operations or Label and Pack.

Education

• As listed in Qualifications