No Deviation is a provider of patient-centric solutions for the pharmaceutical industry, and we are currently seeking individuals who are passionate about joining our team.
Our areas of expertise include engineering consultancy, Commissioning Qualification Validation (CQV), as well as Quality, Compliance, and Regulatory services.
We strongly uphold our core values of Empathy, Integrity, and Transparency, and we strive to create a collaborative, innovative, and inclusive work environment that fosters personal growth and development.
By joining our team, you will have the opportunity to make a meaningful impact in the pharmaceutical industry while advancing your career.
Scopes & 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
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