Area Lead, CQV

AsPackage Lead - CQ, you ll be working with highly skilled Senior Engineersand Engineers and still growing across Denmark and Indian team s where 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 strong leadership qualities to lead a team of CQ Engineers and understanding on stakeholders management at lead role.
• Have knowledge of process equipment s systems
• Lead CQ 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 CQ activities in project and scope of work within quality work package incl. relevant CQ activities
• Ensure changes to scope are brought to the attention of Project Management.
• Ensure interfaces to and coordination with other disciplines
• Review work of project members in the quality work package.
• Generate validation deliverables like IQ, OQ, PQ protocols and reports, etc.
• Act as Smarter Execution consultant for Project Members.
• Ensure CQ documentation is in compliance with GMP and GEP (incl. ASTM E2500).
• Conduct follow-up on QAP planned CQ activities

Whoyou are (Preferred Competencies)
Wecare about who you are as a person. In the end, how you work, and your energyis what impacts the effort we do as a team. As a Biotech person, you:

• Project management skills regarding CQ, facilitating board meetings to review status, timelines, quality, challenges, generating reports for steering group, understanding to evaluate risk and its mitigation strategies.
• Thrives in a fast-paced environment with many concurrent tasks.
• Need to train the team in performing the site activities and handling different stakeholders.
• Support onsite and offsite activities, such as: FATs, SATs, IOQ and PQ Executions and System Walkdowns.
• Hands on experience in planning / directing CQ activities of process equipment s (upstream and downstream and clean utilities) in DS facility qualification
• Should have hands on experience in validation deliverables like URS, design review, PIDs, 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.

Themiles you ve walked (Education and Work Experience)
In all positions there are some things that areneeded, and others a bonus. We believe these qualifications are needed for youto do well in this role:

• Bachelor s or master s degree in a relevant science, engineering, or pharmaceutical field.
• 15 + years experience performing commissioning and / or qualification activities in an FDA regulated industry.
• Ideally you will already have experience in equipment qualification.
• Should have knowledge with recent edition of ISPE CQ and GAMP and regulatory guidelines USFDA, EU GMP, Annexure 11 21 CFR 11 and ICH guidelines.