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Planet Pharma

Sr Engineer - Software

Planet Pharma, Thousand Oaks, California, United States, 91362

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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 - Masters degree & 2 years of directly related experience OR - Bachelors degree & 4 years of directly related experience OR - Associates 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.

Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

Fraud Alert: Candidate safety is a top priority at Planet Pharma. The 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, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.