What are the responsibilities and job description for the Operational Readiness Engineer position at Process Alliance?
Company Overview:
Process Alliance is a leading engineering consultancy firm dedicated to delivering innovative solutions in engineering, automation, manufacturing services, and medical devices. With a commitment to being a better model of problem solving, we have been at the forefront of providing cutting-edge engineering services to clients across the life science industry. Our team of experts thrives on solving complex challenges and driving technological advancements to meet the evolving needs of our clients.
Overview:
We are seeking an Operational Readiness Engineer to support the successful startup, commissioning, and operational handover of new or upgraded pharmaceutical manufacturing systems. This role is ideal for an engineer with strong project execution skills and hands-on experience in commissioning, qualification, and operations support in GMP environments.
Key Responsibilities:
- Support operational readiness planning for new equipment, utilities, and manufacturing areas.
- Own or support Commissioning & Qualification (C&Q) activities including protocol development, execution, and issue resolution.
- Assist with manufacturing equipment and process startup, troubleshooting issues during early batches, and improving operational reliability.
- Develop and update SOPs, batch records, and operational readiness documentation.
- Coordinate operator training, readiness checklists, and manufacturing process walkdowns.
- Drive operational improvements and ensure compliance with GMP, safety, and regulatory requirements.
Required Qualifications:
- Bachelor’s degree in Engineering (Chemical, Mechanical, Biomedical, Industrial, or related discipline required).
- 3–5 years of engineering experience in pharmaceutical, biotech, or other regulated life sciences manufacturing.
- Project management experience supporting capital projects, equipment installation, or cross-functional readiness activities.
- Hands-on experience with startups, C&Q activities, FAT/SAT, or equipment installation.
- Strong understanding of GMP operations, documentation, and validation principles.
- Ability to work collaboratively across engineering, quality, and operations teams.
About Our Culture:
At Process Alliance, we strive to be a better model for how problems are solved, and solutions are delivered. We believe in providing a supportive and inclusive work environment where employees can thrive both personally and professionally. Join our team and be part of a company that is shaping the future of engineering solutions.
Learn more about us:
Visit our website at www.processalliance.com to explore our projects, expertise, and the impact we make in the engineering and consultancy space.
Process Alliance is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences
