The Role
Supports the lifecycle management of automation and computerized systems in a regulated life sciences environment. Responsibilities include PLC and process control system modifications, change controls, system lifecycle documentation, commissioning, acceptance testing, risk assessments, engineering change notices, and project coordination. The role collaborates with Engineering, Quality, Validation, Manufacturing, and Automation teams while maintaining compliant technical and project documentation.
Summary Generated by Built In
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.
Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.
The Experience
With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you decide join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.
We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.
At PSC Biotech®, it’s about more than just a job—it’s about your career and your future.
Your Role
We 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.
Benefits
Offering 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.
Equal Opportunity Employment Statement
PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.
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Skills Required
- 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
- Experience supporting PLC modifications and Process Control System updates
- Experience with PI Historian systems and automated reporting systems
- Experience authoring and maintaining computerized system lifecycle documentation, including 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 CPP and CQA evaluation
- Experience supporting commissioning and implementation of automated manufacturing or process equipment
- 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 United States
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The Company
What We Do
Founded in 1996, PSC Biotech Corporation was created with the vision of providing life science companies unmatched support. To date, PSC Biotech Corporation now serves 1000 clients in more than 35 countries worldwide through professional services consulting, cloud-based software solutions, pharmaceuticals contract manufacturing, life science investment consulting, and metrology services. PSC Biotech Corporation has six unique divisions within the parent company – each representing one of our areas of expertise: PSC Biotech, PSC Software, BioTechnique™, PSC Partners, PSC Metrology and PSC Investments. Additionally, PSC Asia and PSC Biotech Ltd represent PSC Biotech Corporation in Asia and Europe, respectively. Together, these divisions enable us to meet the ever-changing needs of our clients with a commitment to excellence and superior quality.
