Associate Manufacturing Systems Engineer, Biopharma

Associate Manufacturing Systems Engineer, Biopharma

We are looking for an Associate Manufacturing Systems Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Important Notes:

The work schedule for this role will be a first shift (Monday through Friday, approximately 6:30 am to 3 pm) and then move to an off-shift schedule (6pm-6am). As the facility moves into operation, the successful incumbent will be expected to join a shift team structure working to support coverage across the company's 24-hour operations. These shift structures can be a great opportunity to better support individual work/life priorities in Non-Standard Shifts structure.

Pre-screening questions required:

All candidates must have responses to the below pre-screening questions from the job seeker:

1. What PLCs and HMIs do you have experience with?
2. Please explain the process for taking a computer and going online with a PLC step by step.
3. What versions of Rslogix and Studio have you worked with? Follow up question would be is Studio 5000 backwards compatible.
4. If you have Rockwell HMI experience, what versions you worked with and what programming did you do? Have you worked with SE or ME?
5. What vision systems have you worked with? If Cognex or Keyence please list off some of the tools you used to programming (Software, and programing tools)

Job Description:

In this role you will provide technical engineering support on all system/equipment optimization strategies, upgrades, replacements, and modifications. This client's site is new advanced product assembly and packaging plant. You will evaluate and determine if utility systems, process maintenance, instrumentation/ calibration/electrical systems and technical cleaning systems are maintained in compliance with all applicable industry standards, regulatory standards and FDA standards in the Inspection and Packaging area.

Top Must Have Skill Sets:

• PLC Experience
• Electrical Troubleshooting
• Technical Writing Capability
• MUST BE SAFTEY ORIENTED
• PLEASE NOTE SHIFT ABOVE

Preferred Qualifications:

• Educational background in Mechatronics, Computer Science, Electronic Engineering Technology, Computer Engineering or Electrical Engineering
• Understanding in PLC, Computer Serialization, Packaging Equipment, Inspection System
• SCADA/PLC Control System experience in Pharmaceutical, Medical Device or Biotechnology Industry
• Other Automated Control Systems to be supported are: Siemens and Rockwell HMI's, Cognex Vision System, Sensor and Systech Serialization
• Experience with automation system hardware and software support, including installation
• Excellent organizational, project management, problem solving and technical writing capability
• Strong communication: verbal / written, collaboration, influencing and facilitation
• MS Office: Word, Excel, Power Point

Day to Day Responsibilities:

• Take part in the coordination of tech support on engineering, regulatory, compliance, calibration, quality, microbial/environmental, technical cleaning, validation, electrical and process automation issues.
• Assist during regulatory agency inspections. Provide technical support in response to the FDA and other regulatory agencies.
• Complete advanced maintenance activities or operate and monitor sophisticated plant support equipment in accordance with CFRs, cGMPs, SOPs, job plans and company policies. Investigate complex issues or problems through the mentorship of experienced staff.
• Assist the team with maintaining an up-to-date working spare parts inventory system for the equipment/systems the team.
• Evaluate the current maintenance procedures and assist in the changes to optimize the maintenance program, trouble shoot and repair equipment/system failures.
• Interpret and review utility, process system/ equipment, plumbing, ductwork plans, architectural, and HVAC P&ID's.
• Support Operations in Non-Standard shifts that includes weekends and/or holidays as determined by business.

Basic Qualifications:

• High school diploma / GED and 6 years of Technical Engineering experience OR

• Associate's degree and 4 years of Technical Engineering experience OR

• Bachelor's degree

Employee Value Proposition: Unique industry experience

Red Flags:

Job hopping

Minimal work experience

Relocation required*** must be local

Cannot work shift requirement

Interview Process:

30 Minutes with hiring manager

3 person panel 1 hour

We invite qualified candidates to send your resume to View email address on click.appcast.io. If you decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our website You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.