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.
Scope & Responsibilities:
- Responsible for leading Pharma and Biopharma projects using DeltaV System with batch design (CM, EM, Phase, Recipe, etc)
- Responsible for design & managing DeltaV system integrator and ensure they follow company standards and approved guidelines
- Responsible for managing internal stakeholders and coordination with various equipment owners to ensure their requirements are met in the PCS design and is implemented and tested in accordance with the company standards
- Responsible for reviewing functional specifications and design specifications and ensuring these are aligned with project, global and local standards
- Work with various teams to design system architecture, network architecture, cable schedule
- Responsible for reviewing test documents and protocols (FAT, SAT, Interface Test, etc.) so that they meet CSV and QA standards
- Responsible for participating in design meetings at various vendor locations
- Responsible for witnessing FAT’s and interface test at various vendor locations
- Work closely with qualification teams to support qualification test generation and execution efforts in IQ, OQ and PQ
- Support FAT, SAT, IQ, OQ and PQ
Qualifications:
- 10+ years of experience in executing DeltaV Pharma & Biopharma Batch projects
- Extensive knowledge of DeltaV Batch is required
- Understanding of S88 standard is required
- Good understanding of the manufacturing processes
- Good understanding of PLC interfacing with DeltaV
- Experienced in developing automation design philosophies, test plans, protocols and quality reports
- Experienced in developing automation URS, FS, DS from process writeups and tech transfer documents
- Proficiency in written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with other stakeholders
Soft Skills
- Coaching and communication skills
- Good knowledge in coordination of activities
- Must be willing to travel for meetings, and FATs at vendor locations
- Autonomous
- Proactive, self-starter and capable of working alone or in a team environment
- Ability to interpret and operate within defined schedules managing available resources to achieve project milestones
- To be aware and supportive of the project’s requirement for flexibility in working hours/shift patterns through the differing phases of the project’s life cycle
- Experience with Quality Change Control is desirable
