As Senior Engineer - C&Q, you ll be working with highly skilled SeniorEngineers and Engineers and still growing across Denmark and Indian team swhere you ll:
Would like to help making complex biopharma facilities more sustainable.
- Driving the project with Science and Risk based Validation (SRV) concept.
- Work very closely with our customers
- Have high knowledge of process equipment s systems
- Should have knowledge on terminologies of symbols used in PID.
- Execute C&Q activities with multiple stakeholders like (Engineering responsible, Design consultant, Vendor s, and QA) of the project organization
- Align quality and validation concept with customer s quality system & validation concept
- Define scope of C&Q activities in project and scope of work within quality work package incl. relevant C&Q activities
- Ensure changes to scope are brought to the attention of Project Management.
- Generate validation deliverables like IQ, OQ, PQ protocols and reports, etc.
- Act as Smarter Execution consultant for Project Members.
- Ensure C&Q documentation is in compliance with GMP and GEP (incl. ASTM E2500).
- Conduct follow-up on QAP planned C&Q activities
Who you are
We care about who you are as a person. In the end, how you work, and yourenergy is what impacts the effort we do as a team. As a Biotech
person,you: - Thrives in a fast-paced environment with many concurrent tasks.
- Support onsite and offsite activities, such as: FATs, SATs, IOQ and PQ Executions and System Walkdowns.
- Hands on experience in planning / directing C&Q activities of process equipment s (upstream and downstream and CIP) in DS facility qualification
- Should have hands on experience in validation deliverables like URS, design review, P&IDs, FAT, SAT, IQ, OQ, PQs, protocols, and reports generation & execution, etc.
- Should have good communication and collaboration skills enabling interaction with many stakeholders from different functions and cultures.
- Responsible for delivering operational or administrative work where issues are more complex.
- Work is performed entirely independent and might involve leading processes or parts of a larger process.
- Reviews work and ensures coaching and training of more junior colleagues in own discipline.
- Demonstrates subject matter expertise.
- Work requires the ability to handle complex challenges and apply specialist knowledge when adapting solutions.
- Expected to identify better practice and improve procedures, processes, tools, equipment, or techniques.
- Requires some industry specific knowledge and understanding.
- The work requires broad theoretical knowledge and business experience.
- Expected to plan and prioritize own work in a complex and changing environment (VUCA)
- Makes decisions under conditions of uncertainty.
- + Demonstrates subject matter expertise.
- + Proven knowledge of business processes and operating procedures within own functional area or knowledge domain.
- + Ability to coach and train more junior colleagues.
The miles you ve walked
In all positions there are some things that are needed, and others a bonus. Webelieve these qualifications are needed for you to do well in this role: - Bachelor s or master s degree in a relevant science, engineering, or pharmaceutical field.
- Experience performing commissioning and / or qualification activities in an FDA regulated industry.
- Have hands on experience in validation deliverables like URS, design review, P&IDs, FAT, SAT, IQ, OQ, PQs, protocols, and reports generation & execution, etc.
- Should have knowledge with recent edition of ISPE C&Q and GAMP and regulatory guidelines USFDA, EU GMP, Annexure 11 & 21 CFR 11 and ICH guidelines.
