The Role
Supports automation engineering projects in regulated life sciences manufacturing. Responsibilities include managing change controls and ECNs, authoring computerized system lifecycle documents, executing acceptance testing and commissioning protocols, maintaining technical and operational documentation, and ensuring automation system modifications comply with procedures and regulatory requirements. The role collaborates with engineering and technical teams to maintain accurate project and system records through completion.
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 motivated Automation Compliance Engineers to join our team! The Automation Compliance Engineer will support engineering automation projects within a regulated life sciences manufacturing environment, with a primary focus on change control, computerized system lifecycle documentation, commissioning, and compliance activities.
This role will work across automation systems and equipment to ensure system modifications, upgrades, and commissioning activities are properly documented, tested, executed, and closed in accordance with applicable procedures and project requirements.
- Generate, manage, present, and close Change Controls associated with Engineering Automation 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/Design Specifications (FRS/FDS), Configuration Specifications (CS), Software Design Specifications (SDS), Hardware Design Specifications (HDS), and Requirements Specifications (RS).
- Draft, execute, and complete Acceptance Testing and Commissioning protocols, including preparation of final reports.
- Create and update engineering and operational documentation, including job plans, system drawings, calibration datasheets, Standard Operating Procedures (SOPs), work instructions (WRKs), and forms (FRMs).
- Initiate and manage Engineering Change Notices (ECNs) and issue logs through resolution and closure.
- Support the documentation and compliance requirements associated with modifications to automation systems and manufacturing equipment.
- Collaborate with engineering, automation, commissioning, and other cross-functional stakeholders to support successful execution and documentation of system changes.
- Ensure project documentation is accurate, complete, and appropriately maintained throughout the system and project lifecycle.
Requirements
- Bachelor’s degree in Engineering, Automation, Computer Science, or a related technical discipline preferred.
- 5-7 years of relevant experience supporting automation, engineering, commissioning, validation, or compliance activities within a regulated environment.
- Experience with Change Control and Engineering Change Notice (ECN) processes.
- Experience authoring and maintaining computerized system lifecycle documentation such as URS, FRS/FDS, CS, SDS, HDS, and RS documents.
- Experience drafting and executing Acceptance Testing and Commissioning protocols and preparing associated reports.
- Working knowledge of automation and control systems, including PLCs, PCS platforms, and PI Historian systems.
- Experience creating or maintaining technical documentation such as system drawings, calibration datasheets, SOPs, work instructions, job plans, and controlled forms.
- Strong technical writing, documentation, organization, and problem-solving skills.
- Ability to work effectively across engineering and technical teams while managing multiple documentation and compliance activities.
- 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 salary range expected for this role is set between $114,000 - $118,000. 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, Computer Science, or a related technical discipline
- 5-7 years of relevant experience supporting automation, engineering, commissioning, validation, or compliance activities within a regulated environment
- Experience with Change Control and Engineering Change Notice (ECN) processes
- Experience authoring and maintaining computerized system lifecycle documentation, including URS, FRS/FDS, CS, SDS, HDS, and RS documents
- Experience drafting and executing Acceptance Testing and Commissioning protocols and preparing associated reports
- Working knowledge of automation and control systems, including PLCs, PCS platforms, and PI Historian systems
- Experience creating or maintaining technical documentation such as system drawings, calibration datasheets, SOPs, work instructions, job plans, and controlled forms
- Strong technical writing, documentation, organization, and problem-solving skills
- Ability to work effectively across engineering and technical teams while managing multiple documentation and compliance activities
- Must be authorized to work in the United States
- No C2C at this time
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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.
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