About No deviation
At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.
We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.
Position Overview
We are looking for an experienced Senior Process Engineer to lead and support New Product Introduction (NPI) and site projects in biologics. This role involves providing technical expertise on process equipment, ensuring compliance, and optimizing operations. You will manage commissioning, qualification, and technical transfer activities, while collaborating across various departments to drive continuous improvement. Strong project management, leadership, and technical knowledge in biopharmaceutical processes are key requirements. The ideal candidate will have a background in process engineering, validation, and equipment performance within the pharmaceutical manufacturing sector. This is an exciting opportunity to contribute to biologics manufacturing projects and mentor a team of engineers.
Key Responsibilities
- Support NPI and Site projects as Engineering Technical Lead or Subject matter experts for process equipment
- Provide technical expertise in site selection assessment to identify equipment/facility gaps, select new equipment, assess layout/utilities capacity and partner project managers to develop project cost and schedule
- Perform assessment for equipment during new product introduction, change controls and other qualifications activities to ensure equipment are in its validated state
- Subject matter expert for process equipment performance and operation to ensure safety, compliance and sustained operation
- Lead and participate in technical transfer activities and cross-functional meetings
- Work independently and/or with project managers to complete engineering projects of various scales within schedule, budget and quality constraints
- Effectively manage and work with project CQV team to ensure timely delivery of projects
- Responsible for commissioning and qualification activities including FAT, SAT, PSSR, automation checkouts, IQ, OQ, PQ, and asset/preventive maintenance/spare parts creation for new process equipment
- Participate in the system walk-down, ensure the closure of punch items and support the takeover of the system from the project team
- Work closely with project managers to introduce new equipment including development of business case, project charter, user requirement specifications, quality risk assessments, conceptual design, preliminary design, design specifications and detail design
- Participate in design review and setup up of new asset and associated maintenance plan/spares in Maximo
- Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications
- Responsible for investigation of deviations, development of corrective and preventive actions and implementation of change controls in a timely manner
- Develop, implement and optimize maintenance and reliability activities such as preventive maintenance, job plan and datasheet development in Maximo
- Benchmark equipment performance (e.g., reliability, productivity) and determine improvement plans
- Periodically review and/or improve equipment safety, maintenance strategy, spare parts, and other continuous improvement opportunities to enhance reliability
- Responsible for management and oversight of team of CQV engineers
- Develop the best team by coaching and mentoring engineers to develop their technical competency and leadership skills
Required Qualifications
- Doctorate degree in Engineering OR
- Master’s degree in Engineering and 4 years of directly related experience in a pharmaceutical manufacturing site OR
- Bachelor’s degree in Engineering and 8 years of directly related experience in a pharmaceutical manufacturing site
- Able to work independently with minimal of no supervision
- Experience in managing various stakeholders expectations related to process equipment in biopharmaceutical
- Good communications skills, both oral and written, including presentation skills
- Good interpersonal and facilitation skills necessary to forge consensus among competing client interests while ensuring objectives are met
- Strong analytical skills and knowledge of industry trends to identify potential improvement opportunities. Ability to combine technical problem-solving skills with business acumen to determine best business solution
- Working knowledge of biopharmaceutical processes such as chromatography, buffer / media tanks, viral filtration, tangential flow filtration is preferred. Process knowledge on inoculation, bioreactors, harvest, single use technologies and critical utilities will also be considered
- Experience in validation processes such as generation/execution of Installation/Operation/Performance qualification documentation
- Knowledge in Automation systems and processes such as RD’s, Delta-V, BMS, ladder logic and PLC
- Demonstrated project management skills (schedule/cost development, facilitation, collaboration, basic project management, completion and follow-up) and application of concepts
- Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach
- Flexibility to work off-hours
- Knowledge of Total Productive Maintenance, Reliability Centered Maintenance concepts is an added advantage
Why join us?
- Generous Leave Policy including 3 days to care for aging family members, reflecting our commitment to family wellbeing.
- Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
- Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
- Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
- Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.
How to apply
Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!
Please submit your resume, outlining your qualifications and experience relevant to the role, here.