Skip to Main Content

Automation Engineer

Exelead, Inc.
Indianapolis, IN
  • Posted: over a month ago
  • Full-Time
  • Benefits: dental, life insurance, medical, vision, 401k,
Job Description

Position Overview:

The Automation Specialist/Engineer role will serve as the administrator of our facilities automation systems, and all production computerized systems to ensure reliable and compliant operation. The position will apply equipment and process understanding of pharmaceutical manufacturing including operational efficiencies, process design, specifications, vendor management, qualification, safety and asset lifecycle management. Some experience of drug product manufacturing facilities and/or equipment is expected.

 

Major Position Activities & Responsibilities:

Will be the technical expert and administrator on computerized systems such as Allen Bradley,

Honeywell and Wonderware. Responsibilities will include user access management across all

systems supporting facilities, manufacturing and packaging.

• Designs and performs routine maintenance tasks on computerized systems to ensure reliable

operation and proper maintenance of backups.

• Manages site SOPs and practices related to computerized systems to ensure CFR Part 11

compliance with emphasis on data integrity.

• Provides daily support and oversight of site automation and leads periodic reviews of system

performance to identify problem areas and drive continuous improvement.

• Provides end user training for the operator controls of these systems.

• Supports service work and system upgrades, including system administration tasks, coordination

of vendor activities and qualification work.

• Provides ongoing support to maintenance staff to solve complex problems, understand and coach

failure modes, and prepare technical solutions on computerized systems.

• Provides ongoing support to maintenance staff to solve complex problems, understand and coach

failure modes, and prepare technical solutions on computerized systems.

• Will serve as project lead and/or technical subject matter expert on site automation and

computerize system projects.

 

Scope: This position does not supervise any staff, control any budget dollars or have any approval authority.

 

Background Qualifications:

Bachelor’s in Engineering (Computer or Electrical preferred), or equivalence of certifications and

experience.

• Five or more years of experience in a manufacturing environment (pharmaceutical manufacturing

is a plus)

• Knowledge of CFR Part 11 (EudraLex Volume 4 Annex 11 and ISPE GAMP Guidelines a plus)

• Building Automation Systems programming, troubleshooting and administration

• Knowledge of Computerized Systems qualification/validation

• Knowledge of Supervisory Control and Data Acquisition systems (SCADA) preferred

• Must have good written and verbal skills

• Requires manual dexterity, physical agility and the ability to lift 60 lbs.

Company Description
At Exelead, we approach contract manufacturing with focused expertise on liposomal and PEGylated formulations to treat rare diseases and small or underserved populations. We specialize in the development and manufacture of lipid-based, parenteral drug products, and our team has more than 20 years' experience working with a wide range of preclinical, clinical and commercial customers.

Exelead, Inc.

Why Work Here?
Join a team and company that truly changes lives!

At Exelead, we approach contract manufacturing with focused expertise on liposomal and PEGylated formulations to treat rare diseases and small or underserved populations. We specialize in the development and manufacture of lipid-based, parenteral drug products, and our team has more than 20 years' experience working with a wide range of preclinical, clinical and commercial customers.

Address

Indianapolis, IN
USA

Industry

Manufacturing

Website

View all jobs at Exelead, Inc.

What email should the hiring manager reach you at?

By clicking the button above, I agree to the ZipRecruiter Terms of Use and acknowledge I have read the Privacy Policy, and agree to receive email job alerts.