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Process Engineer & OpEx Lead

Company: Piramal Enterprises Ltd.
Location: Michigan
Posted on: June 10, 2021

Job Description:

POSITION SUMMARY: Piramal Pharma Solutions' HPAPI Research and Manufacturing facility, located in Riverview, Michigan (Ash Stevens, LLC, hereafter referred to as PPS-Riverview), is seeking a qualified Process Engineer & Operational Excellence (OpEx) Lead to join our Technology Transfer team.

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 for the continual improvement for the site. Drive ideation every year to optimize cost, productivity, and Manage Projects throughout the plant in all the departments.
  • Conduct Kaizen and KPI competition amongst team, sharing OE best practices across various plants in the organization.
  • Lead focused improvement teams & daily management teams and show improvements in chosen KPIs.
  • Be the subject matter expert in the use of Lean and Six Sigma tools & methodology; ensure that the tools are used appropriately by team members. Identify, and assist in the removal of barriers to projects.
  • Report project status and financial results, ensuring 2-way open communication throughout the functions/ organization for Operational Excellence.
  • Responsible for conceptualizing and managing various cross-functional business initiatives in project mode with the use of analytical techniques.
  • Responsible for working with Technology Transfer and the Client to generate, revise, and approve master production records (MPRs) and any other documents associated with the commercial products in the manufacturing, e.g. SOPs, material specifications, technical reports, etc.
  • Preparing unplanned and planned deviations for responsible processes and forming the investigation team.
  • Collaborates with PD, Technology Transfer, Ops, Quality Control (QC), and Quality Assurance (QA) in problem solving activities, including deviation writing and CAPA closure.
  • Work with project and engineering teams to replace, modify, or buy equipment for continuous improvement and/or capacity enhancement.
  • Responsible for training GMP Manufacturing personnel on the new production process.
  • Functions as the technical interface between Piramal Riverview and the Client, focusing on providing technical advice and support, engineering solutions, oversee GMP runs in the plant equipment, and analyzing of production data for evaluation of process performance and writing production summaries.
  • Requires solid understanding of the manufacturing processes, GMP guidelines, site and corporate policies and procedures, hands-on experience, and full understanding of production processes in the GMP environment as laid out at site.
  • Willingness to work flexible hours and shifts when there is a need.
  • Responsible for providing independent production support during off-hours.
  • Ability to travel as needed.
  • Generate URS (user requirement specification/Design basis) for capital requests and/or equipment/facility modifications.
  • Participate in site PHA and HAZAOP studies for facilities and projects.
  • Ensure process data is being updated on a monthly basis; analyze manufacturing KPI performance for improvement and discussion with client. Coordinate the qualification of primary and secondary regulatory starting material suppliers for assigned projects.
  • Take part in the Operational Excellence activities in the plant.

KEY INTERACTIONS.

  • Internal: Technology Transfer; Process Development; Quality Assurance; Quality Control; Supply Chain; Facilities & Maintenance; Warehouse; EHS; Operation Excellence
  • External: Clients; Engineering companies and vendors

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 is in compliance with 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.
  • Master's Degree or PhD preferred, in lieu of work experience.

  • At least 1-3 years of relevant work experience in the pharmaceutical industry.
  • Demonstrated project management and technical leadership capabilities.
  • Confident management of internal and external stakeholder relationships.
  • Good written and oral communication skills.
  • Demonstrated teamwork skill and professionalism in all interactions.
  • Proven track record of successful technology transfer.
  • Working knowledge of process and desktop computers.

job conditions.

The physical demands and work environment described here are representative of those that must be met by a team member to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. If any accommodations are needed, requests should be made to our Human Resources department.

  • Physical Demands:
  • Frequent lifting, bending, stooping, squatting, pushing and pulling can be expected.
  • Long periods of standing and walking can be expected in this position.
  • This position may require long periods of sitting, typing, computer entry or looking at a computer.

  • Work Environment:
  • Piramal Pharma Solutions is engaged in the business of pharmaceutical research and contract pharmaceutical manufacturing. As such, all PPS staff work in or nearby either chemical/pharmaceutical research or chemical/pharmaceutical manufacturing equipment and processes.
  • Potential limited exposure to hazardous chemicals.
  • Personal protective equipment including safety glasses, lab coats, gloves, specialized clothing including laboratory uniform and appropriate shoes may be required in areas associated with this position.

equal employment opportunity.

Piramal Pharma Solutions is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

Keywords: Piramal Enterprises Ltd., Fargo , Process Engineer & OpEx Lead, Other , Michigan, North Dakota

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