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Planet Pharma
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https://www.planet-pharma.com
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Pay range: 63-73/hr
*depending on experience
Job Responsibilities include:
1) Developing process control applications utilizing Programmable Logic Controllers (PLC), Distributed Control Systems (DCS), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA).
2) Support projects focused on improving process equipment/utilities/facilities -to- sophisticated unit operation skids to integrate new drug product manufacturing technologies into clinical/commercial facility.
3) Familiarity with industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP.
4) Development of detailed specification, engineering documents, SOP and computerized system administration job plans. Testing of automation-based process equipment.
5) Ownership and administration of process control automation in a GMP regulated manufacturing setting. Engage in process change control requests per established SOP and processes.
6) Lead technical root cause analysis, incident investigations, and troubleshooting on process control issues related to mechanical, electrical, instrumentation and control systems.
7) Support new product introductions or new technology introductions by performing engineering assessments, implementing automation system configuration changes and supporting engineering runs.
8) Devise new approaches to complex problems through adaptations and modifications of standard automation technical principles.
9) Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations
Basic Qualifications
Doctorate degree OR - Master’s degree & 2 years of directly related experience OR - Bachelor’s degree & 4 years of directly related experience OR - Associate’s degree & 8 years of directly related experience OR – High school diploma / GED & 10 years of directly related experience
Preferred Qualifications
1) B.S or M.S. in Electrical Engineering, Chemical Engineering, Mechanical Engineering, or Biotech Engineering.
2) Strong control system automation background focused specifically in design, installation, programming and validation of automated processes are essential.
3) 5 or more years combined experience with Rockwell Automation Factory Talk & ControlLogix PLC Platform.
4) Ability to create, update and read electrical design packages including SDS, URS, IQ, OQ and VSR among other engineering and validation documentation.
5) Knowledge of S88 and S95 techniques. - Batch processing a desired advantage.
6) Strong leadership, technical writing, and communication/presentation skills are required.
7) Work schedule flexibility as required to support 24/7 operations, requiring daily on-site and occasional after-hours engineering coverage.
8) Experience in developing automation strategies for New Product Introduction and New Technology Deployment.
9) Preferred Experience using the following systems:
a. Lyophilizer System, Filling systems for Syringe and Vials and Building Management System
b. Testing and Inspection machines for devices
c. Clean Utilities (WFI Still A\B, Clean Steam Generator, Chemical Dist. System, WFI Storage & Distribution and Purification System)
d. Cleaning Systems (Autoclaves, Depyro oven, COPs and Glass Washers, Pressure Vessel Washer, Vial Washer and Ultrasonic Washer)
10) Position requires a working knowledge of building automation systems, electronic batch records, PLC, OPC, Profibus, Ethernet/IP and DeviceNet technologies.
11) Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment. Candidate should be experienced in change control, nonconformance, corrective and preventative actions, and validation practices.
12) Must be independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration. Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
Sr Engineer - Software
Posted: 05/30/2025
2025-05-30
2025-07-12
Employment Type:
Contract
Job Category: Engineering
Job Number: 620049
Is job remote?: No
Country: United States
Job Description
Pay range: 63-73/hr
*depending on experience
Job Responsibilities include:
1) Developing process control applications utilizing Programmable Logic Controllers (PLC), Distributed Control Systems (DCS), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA).
2) Support projects focused on improving process equipment/utilities/facilities -to- sophisticated unit operation skids to integrate new drug product manufacturing technologies into clinical/commercial facility.
3) Familiarity with industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP.
4) Development of detailed specification, engineering documents, SOP and computerized system administration job plans. Testing of automation-based process equipment.
5) Ownership and administration of process control automation in a GMP regulated manufacturing setting. Engage in process change control requests per established SOP and processes.
6) Lead technical root cause analysis, incident investigations, and troubleshooting on process control issues related to mechanical, electrical, instrumentation and control systems.
7) Support new product introductions or new technology introductions by performing engineering assessments, implementing automation system configuration changes and supporting engineering runs.
8) Devise new approaches to complex problems through adaptations and modifications of standard automation technical principles.
9) Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations
Basic Qualifications
Doctorate degree OR - Master’s degree & 2 years of directly related experience OR - Bachelor’s degree & 4 years of directly related experience OR - Associate’s degree & 8 years of directly related experience OR – High school diploma / GED & 10 years of directly related experience
Preferred Qualifications
1) B.S or M.S. in Electrical Engineering, Chemical Engineering, Mechanical Engineering, or Biotech Engineering.
2) Strong control system automation background focused specifically in design, installation, programming and validation of automated processes are essential.
3) 5 or more years combined experience with Rockwell Automation Factory Talk & ControlLogix PLC Platform.
4) Ability to create, update and read electrical design packages including SDS, URS, IQ, OQ and VSR among other engineering and validation documentation.
5) Knowledge of S88 and S95 techniques. - Batch processing a desired advantage.
6) Strong leadership, technical writing, and communication/presentation skills are required.
7) Work schedule flexibility as required to support 24/7 operations, requiring daily on-site and occasional after-hours engineering coverage.
8) Experience in developing automation strategies for New Product Introduction and New Technology Deployment.
9) Preferred Experience using the following systems:
a. Lyophilizer System, Filling systems for Syringe and Vials and Building Management System
b. Testing and Inspection machines for devices
c. Clean Utilities (WFI Still A\B, Clean Steam Generator, Chemical Dist. System, WFI Storage & Distribution and Purification System)
d. Cleaning Systems (Autoclaves, Depyro oven, COPs and Glass Washers, Pressure Vessel Washer, Vial Washer and Ultrasonic Washer)
10) Position requires a working knowledge of building automation systems, electronic batch records, PLC, OPC, Profibus, Ethernet/IP and DeviceNet technologies.
11) Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment. Candidate should be experienced in change control, nonconformance, corrective and preventative actions, and validation practices.
12) Must be independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration. Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.
Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.
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