Manager, CapEx, Process Engineering

7/5/22

Riverview, MI

1744

Manager, Process Engineering

POSITION SUMMARY: seeking a qualified Manager, Process Engineering & Capital projects to join our Operations team. The Manager, Process Engineering & Capital projects, will have a technical understanding of chemistry, process engineering and equipment in a pharmaceutical chemical manufacturing facility and will execute major capital projects support current and future expansions & support process engineering to manage processes at the site.

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.
  • Identify and protect the original technical information as part of the company property.

Key responsibilities.

  • Capital Projects - New Facilities and Equipment
    • Design processes and equipment for large-scale manufacturing, engineer must be hands on all new process technologies and manufacturing equipment.
    • Preparations of the User requirement specification (URS) of the major Equipment. Co-coordinating URS of other functions: Facility, Utility and infrastructure, Warehouse, Kilo Labs, Offices, Locker rooms and others. Preparation of Technical specs, review of vendor documents / drawings.
    • Define, evaluate and prepare engineering standard, scope of work, materials and equipment’s of the projects.
    • Review of the Process Flow Diagrams (PFD), Piping & Instrumentation Diagrams (P&IDs), Engineering drawings from the design engineering consultants.
    • Take part in Technical & Commercial Bidding Analysis (TBA/CBA) of key process equipment
    • Project Management, Project budgeting and costing, execution of projects, etc.
    • Process Engineering, Process Design, Material & Energy Balances equipment Design.
    • Responsible for quality and workmanship of site project activities.
    • Verification of construction, Technical specs along with review of vendor documents / drawings.
    • Commissioning new facilities, including:
  • IQ, OQ, PQ
  • Debugging facilities, equipment, and systems
  • Supervising installations
  • Troubleshooting
  • Supervising initial start-up
  • Evaluating equipment performance
  • Ensure proper operator training on new equipment
  • Support development of new process technologies from concept to commercialization.
  • Responsible of the process engineering activities for the existing plant. Projects related to CAPA closures and process improvement of the site
  • Existing Facilities and Equipment (Plants, Labs, Quality Control, and Safety)
    • Support meeting Key performance Indicators: Safety (Loss time and Recordable incidents rate), Right First time and project deliverables on time within budget
    • Promoting operational excellence culture and delivering operational excellence projects
    • Recommend, justify, and manage processing equipment improvements or upgrade projects.
    • Troubleshoot facility and equipment problems and implement timely and cost effective solutions as needed.

EDUCATION/EXPERIENCE.

  • Bachelor’s degree in chemical engineering is required.
  • Minimum ten (10) to fifteen (15) years’ experience of API manufacturing and/or Process/Project management and/or pharmaceutical development experience.
  • Previous experience with pharmaceutical processing and all relevant aspects of a facility, including infrastructure, processing equipment, and utilities.
  • Demonstrated proficiency with current Microsoft Office suite especially Microsoft projects and ability to use/understand CAD software helpful.
  • Additional education and/or training in management is strongly preferred.

job competencies.

  • Excellent organizational and planning skills.
  • Strong written, verbal, and interpersonal communication skills.
  • Demonstrated ability to collaborate with other ASI team members and/or outside vendors/contractors.
  • Strong time management skills, including adjustment of work schedule as needed in order to meet project deadlines and commitments.
  • Project management skills for the implementation and management of engineering projects to deliver on time, on budget and meeting specifications, while collaborating with ongoing operations for successful project implementation.
  • Financial acumen for budgeting purposes.
  • Strong knowledge of applicable regulatory requirements, including cGMP, FDA, (MI) OSHA, and EPA.
  • Familiarity with quality systems and experienced in validation of equipment/facility validation (URS, F/SAT, DQ, IQ, OQ, PQ, etc.).
  • Operation Excellence tools – Lean and Six Sigma
  • Influencing and persuasion skills
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