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Piramal Pharma Solutions
Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.
This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.
Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.
For more details, please visit : www.piramalpharmasolutions.com
Job Title
Operational Excellence Engineer
Job Description
Piramal Pharma Solutions' Formulation and Manufacturing facility, located in Lexington KY, is seeking a qualified Process Engineer & Operational Excellence (OpEx) Lead to join our Regional OE team and support the Lexington site.
POSITION SUMMARY: Piramal Pharma Solutions (PPS) Contract Development and Manufacturing Operation (CDMO), located in Lexington KY, is seeking a qualified Operational Excellence Engineer.
To perform this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required:
• Shall adhere to all applicable regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices.
• Consistent support and practice of all Piramal Pharma Solutions mission, vision, and values.
• Identify and protect the original technical information as part of the company property.
KEY RESPONSIBILITIES.
• Responsible to deploy the practices across the site / functions as per the corporate OE plan.
• Responsible to conceptualize and manage various cross-functional business initiatives in project mode with the use of analytical techniques and change management methodologies.
• Facilitate the site strategy deployment process effectively and efficiently, toward the objective of Zero Defects, Zero Deterrents, Zero Harm, and Zero Waste.
• Enable the site to take challenging targets and navigate with the teams to achieve the financial savings & KPI targets. Report project status and financial results, ensuring 2-way open communication throughout the functions/ organization for Operational Excellence.
• As an expert in the use of Lean, ToC and Six Sigma tools & methodology, responsible to coach and guide the users on utilizing these tools appropriately implement projects, drive problem-solving and break down operating constraints. Proactively identify obstacles and assist in managing projects and execution.
• Facilitate Lean Six Sigma capability development - White Belt, Yellow Belt, and Green Belt training programs and govern the certification process. Review and guide project leads/teams to complete the projects as per methodology.
• Drive the deployment of the daily management system (DMS) as per the corporate guidelines and OE framework. Define the strategy for the DMS roll-out, deployment, and maturation at the site. Ensure the team's capability on the DMS standards is enhanced through training & coaching events. Seek the support of the central and regional OE/DMS team and experts on driving the agenda.
• Conduct data analytics and diagnostics to identify improvement opportunities in processes. Drive thematic improvement projects to enhance Productivity, Quality, Cost, Delivery, and Safety continuously. Ensure the key burning issues of the sites are translated adequately through the Performance Management System (PMS) standard, across the tiers.
• Effectively program manage the Kaizen competition and Ideas Management program for site. Ensure the horizontal deployment of OE best practices from network sites is rollout at the site.
• Help the site achieve their financial saving targets and the other KPI targets.
• Ensure the reporting and review of monthly OE and KPIs MIS via the established OE governance model with site leadership team, global / regional OE heads.
• Support the organization digitalization journey while engaging in the strategic and tactical digital use cases deployment.
• Support with preparation of reports, presentations, site leadership team meetings and other documents as required by site head / global / regional OE.
• Perform any other duties or responsibilities consistent with the employee Role and assigned by the management.
COMPLIANCE WITH POLICIES AND REGULATIONS:
• Compliance with 21 CFR - Parts 210/211, EU Directives 91/356/EEC and ICH Q7.
• Compliance with SOPs, batch records, forms, logs of use and quality agreements.
• Recognize common sources of failure and improve documentation to reduce deviations and errors.
• Work with Operations personnel to improve compliance.
• Ensure work follows all state and federal regulations, including but not limited to OSHA, GMP, DEA, FDA, etc.
• Assist in the formulation of corrective procedures when needed.
• Use appropriate PPE while inside a manufacturing area.
• Assume responsibility for safety and knowing the appropriate emergency procedures in case of emergency.
• Know the location of SDS binders and understand how the guidelines pertain to employees.
EDUCATION/EXPERIENCE.
• Bachelor's degree in chemistry or engineering or similar pharmaceutical discipline is required.
o Master's Degree or PhD preferred, in lieu of work experience.
• At least 3-5 years of relevant work experience in the pharmaceutical industry.
• Strong communication skills
• Ability to build a strong working relationship with all stakeholders
• Demonstrate high levels of Ownership & Accountability.
• Ability to organize the work, plan well and prioritize based on impact
• Action-oriented and results-driven.
• Analytical with strong command over MS Excel, MS PowerPoint, Data Analytics and Minitab
• Exposure to Industry 4.0 concepts