Job Description Your RoleWe are hiring an experienced Automation Process Engineer to join our team! The Automation Process Engineer will support the execution and lifecycle management of automation and computerized systems within a regulated life sciences environment. This role will be responsible for automation-related change controls, system documentation, commissioning and acceptance testing, risk assessments, and engineering project activities.
The ideal candidate will have hands-on experience with PLC and process control system modifications, computerized system lifecycle documentation, and commissioning of automated equipment and systems.
- Generate, present, manage, and close Engineering Automation Change Controls associated with automation and equipment projects.
- Support automation changes involving Programmable Logic Controllers (PLCs), Process Control Systems (PCS), PI Historian systems, Vantagepoint reporting, and equipment commissioning.
- Author and maintain computerized system lifecycle documentation, including User Requirements Specifications (URS), Functional Requirements Specifications/Functional Design Specifications (FRS/FDS), Configuration Specifications (CS), Software Design Specifications (SDS), Hardware Design Specifications (HDS), and Requirements Specifications (RS).
- Develop and update engineering documentation, including job plans, system drawings, calibration data sheets, Standard Operating Procedures (SOPs), work instructions (WRKs), and forms (FRMs).
- Draft, execute, and document Acceptance Testing and Commissioning protocols, including preparation of final reports.
- Initiate, manage, and support resolution of Engineering Change Notices (ECNs) and project Issues Logs.
- Perform system and equipment risk assessments to identify and evaluate relevant Critical Process Parameters (CPPs) associated with system Critical Quality Attributes (CQAs).
- Provide project management support for automation and engineering initiatives, including coordination of project activities, documentation, deliverables, and issue resolution.
- Collaborate with Engineering, Automation, Quality, Validation, Manufacturing, and other cross-functional stakeholders to support successful project execution.
- Maintain project and system documentation in accordance with applicable site procedures and regulated-industry requirements.
Requirements- Bachelor's degree in Engineering, Automation, Chemical Engineering, Electrical Engineering, Computer Engineering, or a related technical discipline.
- 7-10 years of relevant experience in automation, process engineering, controls engineering, or a related engineering function within a regulated environment.
- Demonstrated experience supporting PLC modifications and Process Control System (PCS) updates.
- Experience with PI Historian systems and automated reporting systems.
- Experience authoring and maintaining computerized system lifecycle documentation such as URS, FRS/FDS, CS, SDS, HDS, and RS documentation.
- Hands-on experience drafting and executing Acceptance Testing and Commissioning protocols and associated reports.
- Experience with engineering change management processes, including Change Controls, ECNs, and issue resolution.
- Working knowledge of equipment and system risk assessments, including evaluation of CPPs and CQAs.
- Experience supporting the commissioning and implementation of automated manufacturing or process equipment.
- Demonstrated ability to manage engineering projects, priorities, documentation, and cross-functional deliverables.
- Strong technical writing, documentation, communication, and problem-solving skills.
- Ability to work effectively with Engineering, Quality, Validation, Manufacturing, and Automation stakeholders in a regulated environment.
- Must be authorized to work in the U.S.
- No C2C at this time.
BenefitsOffering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.
- Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
- Insurance options for Employee Assistance Programs, Basic Life Insurance, Long Term Disability and more
- 401(k) and 401(k) matching
- PTO, Sick Time, and Paid Holidays
- Education Assistance
- Pet Insurance
- Fitness Perks and Discounted Rates
- Financial Perks and Discounts
Adhering to the requirements of U.S laws on pay transparency, the hourly range expected for this role is set between $57 - $62. The rate offered may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.
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