Sr. Manager Validation
Arranta Bio is a rapidly growing and dynamic bio-pharmaceutical contract development and manufacturing organization (CDMO). Our vision is to be the best in class CDMO providing development and GMP manufacturing services to microbiome innovators within the pharmaceutical industry. Therapies focused on the human microbiome are exhibiting incredible potential towards revolutionizing disease etiology and associated medical treatments. Arranta Bio's mission is to build a world class organization which provides microbiome bio-pharmaceutical innovators with a single source of supply from early process development through clinical and commercial GMP finished product.
WHO ARE WE
Arranta hires people who are committed and passionate to the goal of bringing life enhancing products to patients. We want top talent who will render ideas and a relentless desire towards accomplishing our mission; when a job becomes a passion, it makes you feel ALIVE.
Here at Arranta Bio, we embrace ALIVE - our core values that we live and breathe daily! We are Agile, Leading, Innovating, Value Creating, and Engaging.
We embrace our challenges as opportunities.
We are empowered to think and act.
We never settle; we strive to improve through purposeful creativity.
We build aligned teams who learn, grow, and deliver.
We are committed to building strong relationships.
Are you ready to come ALIVE with a daring and intrepid team? Don't wait another minute; Apply today!
The Senior Manager, Validation will be a hands-on, subject matter expert in the commissioning, qualification, verification, and validation program and provide leadership to manage the site validation of equipment, utilities, computer systems, cleaning, and processes. Responsibilities include developing and managing site validation master plan and deliverables; managing all validation life cycle activities to support the site, performing gap analyses to User Requirements, developing plans, protocols, and reports that comply with company procedures, regulations, and industry best practices. The ideal candidate will have strong understanding of risk-and science-based approach to validation and experience with process risk assessments including FMEAs.
ESSENTIAL JOB FUNCTIONS
- Manage Site Validation Master Plan and deliverables
- Serve as site subject matter expert in validation to support regulatory inspections and client audits
- Develop validation lifecycle policies and procedures in alignment with regulatory standards and industry best practices
- Manage site validation activities to support projects
- Support change controls for complex process, validation, analytical, equipment, facility/utility and/or automation changes
- Author or manage authoring of qualification and validation plans, validation protocols, validation summary reports and requirement trace matrices.
- Reviews and approves qualification and validation deviations and discrepancies, supports investigations and corrective actions
- Participate in design reviews and have experience in reading P&ID's and various engineering drawings
- Manage computer system validation
- Review project documentation (URS, Technical Specifications, and Functional Specifications).
- Participate in discussions with internal business partners on priorities, timelines and transparent sharing of information.
- Manage site periodic review program and ensure a validated state is maintained.
The individual selected for this role must be ab excellent collaborator, understanding how to communicate and participate in a team successfully.
- A leader and role model
- Hands-on, self-motivated
- Team player
- Willing and able to make decisions based on risk
- Reliable, driven, and organized
- Attention to detail, high concern for standards, and results oriented
- Excellent communication skills (oral and written)
Experience and Skills
EDUCATION AND/ OR EXPERIENCE
- Bachelor's degree in Engineering, Science or related technical field
- Excellent technical writing and verbal communication skills
- Minimum of 8 years of experience in late-phase or commercial biotechnology GMP manufacturing operations including experience in cell culture or fermentation, purification, and lyophilization
- Minimum of 5 years management experience
- In-depth knowledge of FDA regulations 21 CFR part 11, 210, 211, 600 and corresponding EU regulations
- In-depth knowledge of ICH Q7 Q8, Q9, Q10 and other international regulatory requirements
- Proficiency in Microsoft Word, Excel, PowerPoint, Project, and Visio
- Ability to prepare contingency plans and logically work through complex issues in a high-pressure situation
- Able to work a flexible schedule.
- Lifting, walking, repetitive hand motions and attentiveness required
- The ability to gown and work successfully in a manufacturing environment
Arranta Bio is an Equal Opportunity Employer.