Responsibilities:
- Execute commissioning, qualification, and validation (CQV) activities for mechanical equipment and systems utilized in Biopharma manufacturing facilities, adhering to regulatory standards and industry best practices.
- Create, assess, and implement validation protocols and reports for mechanical systems and equipment.
- Engage in the formulation of Standard Operating Procedures (SOPs) relevant to CQV processes.
- Conduct risk assessments to identify and analyze potential hazards associated with mechanical equipment and systems in Biopharma production.
- Offer technical support for HVAC and design tasks, including the design, commissioning, and validation of HVAC systems and equipment.
- Collaborate with internal and external partners to provide technical insights and assistance for HVAC and design-related projects.
- Review and provide feedback on engineering drawings, equipment specifications, and design documents.
- Manage administrative duties related to CQV, HVAC, and design activities, including scheduling, tracking, and document management.
- Lead and oversee small CQV, HVAC, and design projects as assigned, coordinating project team members and ensuring adherence to deadlines.
- Ensure compliance with regulatory standards, including cGMP, FDA, and ICH guidelines.
- Stay updated on industry trends and best practices concerning CQV, HVAC, and design activities, offering recommendations for ongoing improvement.
- Demonstrate strong interpersonal, written, and verbal communication skills.
- Contribute to and support high-performing, cross-functional teams.
- Adhere to client-specific work instructions, policies, and procedures.
- Act as a subject matter expert in the manufacturing process.
- Analyze and document production data using standard scientific methodologies.
- Assist with troubleshooting throughout the project lifecycle as needed.
- Participate in multiple projects or tasks of moderate scope and complexity as part of a team, requiring minimal supervision.
- Provide coaching in computerized system validation, hardware qualification, and IT compliance.
- Support business development initiatives.
Profile:
- Completed scientific or technical studies (e.g., Pharmacy, Biotechnology, Engineering, Chemistry).
- Minimum of 6 years of practical experience in a biopharmaceutical laboratory or process environment.
- Strong understanding of GMP and comprehensive knowledge of additional regulatory requirements (FDA, EU, GxP, ISO13485, GAMP5).
- Experience in validating equipment, systems, and processes in a pharmaceutical manufacturing setting (preferably in a greenfield context).
- Familiarity with statistical analysis tools and techniques for data evaluation, including Design of Experiments (DoE) and Statistical Process Control (SPC).
- Basic knowledge of networking and system setup.
- Understanding of manufacturing process steps and fundamental concepts of software programming.
- A self-starter capable of working independently and collaboratively in a team setting.
- Proven experience with SAT for commissioning production equipment.
- High quality awareness, excellent communication skills, and the ability to work within interdisciplinary teams.
- Willingness to travel.
- Customer-oriented approach to work
