Sr. Validation Engineer
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 Sr. Validation Engineer will be responsible for developing a variety of validation documents including validation test protocol and reports, SOPs, Validation Plan, and URS based on the regulatory agency requirements, internal company standards, and current industry practices.
ESSENTIAL JOB FUNCTIONS
Lead the execution of complex validation activities and validation assignments involving the qualification of new and existing facilities, utilities, equipment, and/or computerized systems.
Write, execute, and lead facilities and equipment validations, reviewing and analyzing data, adhering to GMP regulations.
Review and approve project documentation related to validation (URS, Technical Specifications, Functional Specifications, Validation protocols, and reports).
Author and update validation department SOPs
Support cross-functional teams to establish validation plans and deliverables.
Participate in equipment failure investigations and resolve all deviations and non-conformances reported during validation/qualification
Coordinate testing schedule with impacted area managers and quality control based on project needs
Contribute to the successful completion of project milestones and crucial technical tasks
Demonstrate a strong understanding of engineering fundamentals.
Coordinate calibration activities.
Communicate project plans, status updates, and progress against milestones to project team members.
Knowledge of ICH Q9 Guidance, ASTM E2500, and ISPE GAMP 5 guidelines.
Experience and Skills
EDUCATION AND/ OR EXPERIENCE
BS required, MS preferred in a scientific/technical discipline with 5+ years of experience in a validation position within the biological and/or pharmaceutical industry.
Ability to apply GMP regulations and international guidelines to all aspects of the position
Exceptional interpersonal skills including the ability to influence behaviors and negotiate and resolve challenges with poise, tact, and diplomacy
Exceptional oral and written communication skills to all organization levels as well as clients and vendors
Strong organizational skills; able to prioritize and manage through complex processes/projects
Extensive experience with writing and managing investigations and risk assessments
Ability to write reports, business correspondence and SOPs
Ability to be hands-on and detail orientated
Very proficient in MS Office application suite as well GMP electronic applications such as LIMS
Bending, standing, walking, lifting, sitting, carrying, repetitive motions typing- filing – writing,
Ability to lift and carry 10 pounds
The ability to gown and work successfully in a manufacturing environment
- Phone reimbursement policy for qualified individuals
- Free parking
- Highly competitive healthcare with many plan options:
- Medical (HMO/PPO/EPO)
- Flexible Spending Accounts for medical expenses and dependent care expenses
- Up to 10 weeks of 100% paid maternity leave
- 2 weeks of 100% paid paternity, domestic partner, & adoption leave
- Educational assistance program
- 401k (traditional and Roth offered) with 100% match on first 5% deferred.
- A suite of Arranta Bio paid insurance coverage, including life insurance, short-term and long-term disability
- Voluntary legal assistance plan
- Employee Referral program
- Competitive PTO plan, in addition to 10 company paid holidays (includes 2 floating holidays)