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Senior Process Engineer II more...
Location:Chelsea, MA
Company:Acorda Therapeutics Inc.
First posted:January 27, 2017 (last updated 30+ days ago)
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Senior Process Engineer II

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Location

Chelsea, MA, United States

Summary

The Senior Process Engineer II is responsible for the design and implementation of manufacturing processes, instrumentation and equipment for clinical and commercial manufacturing.  This individual provides expertise in engineering, design and process scale-up.  The Senior Process Engineer II develops and recommends new process formulas and technologies to achieve cost effectiveness and robust manufacturing. 

Full Description

The Senior Process Engineer II is responsible for the design and implementation of manufacturing processes, instrumentation and equipment for clinical and commercial manufacturing.  This individual provides expertise in engineering, design and process scale-up.  The Senior Process Engineer II develops and recommends new process formulas and technologies to achieve cost effectiveness and robust manufacturing. This individual establishes operating equipment specifications and improves manufacturing techniques. The Senior Process Engineer II is involved in new product scale-up, process optimization, technology transfer and process validation activities. 

* Essential Duties and Responsibilities include the following. Other duties may be assigned.

  • Provides engineering expertise to the design, specification and installation of pharmaceutical manufacturing equipment.
  • Partners with Process Development for technology transfer and scale-up activities.
  • System ownership of pharmaceutical equipment and/or processes including the following:
    • Responsible for specification, design, installation, and commissioning of new equipment
    • Drafts and maintains Standard Operating Procedures and Batch Records
    • Responsible for process/equipment troubleshooting and technical support
    • Trains of Manufacturing and Facilities staff
  • Leads technical aspects of equipment/process investigations.
  • Assists the manufacturing operation in problem solving with regards to equipment and systems.
  • As technical owner of process equipment (Formulation Vessels, CIP Skids and Spray Dryers) interfaces with various departments (Manufacturing, Development, Facilities, QA and QC) to ensure processes and equipment designs are complete for new product implementations.

Education and/or Experience:

  • Bachelors degree in Chemical Engineering or related field is required.
  • Masters degree in Chemical Engineering or related field is preferred.
  • Minimum 12-15 years of related industry experience is required
  • Experience working in a FDA regulated operation, preferably in the pharmaceutical/biotechnology area is required.

Supervisory Responsibilities: None

Qualifications:

  • Must have strong mechanical, electrical and process hands-on capabilities.
  • Must have strong equipment/process design capabilities as it relates to Formulation Vessels, CIP, and Spray Drying.
  • Must have strong understanding of cGMPs as they pertain to clinical and commercial pharmaceutical manufacturing.
  • Must be able to demonstrate appropriate safety consciousness.

Computer Skills:

  • Must be proficient in MS Office Suite.
  • Must be familiar with process control systems (e.g. Rockwell FactoryTalk).

Certificates, Licenses, Registrations: N one required

Other Skills and Abilities:

  • Excellent written and verbal communication skills.
  • Ability to prioritize and multi-task successfully in a fast paced environment.
  • Excellent organizational skills with the ability to handle multiple tasks.
  • Must be able to work well independently and in a team environment.

Physical Demands:

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

  • Must have the ability to lift up to 50 pounds.
  • Requires physical activity such as standing for long periods of time, walking, and working with hands.
  • This position requires minimum travel; the average travel for this position is 5-10% with some variation based on the demands of business imperatives.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

  • Must be able to work in a controlled or clean room environment requiring special gowning.
  • Must have the ability to work safely and conscientiously in a manufacturing environment.
  • Some weekends or holidays may be required.
  • May require adjustment to a shift schedule as manufacturing objectives change.

*To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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