Validation Engineer

ABOUT US

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!

JOB SUMMARY

This position will be responsible for developing and executing the Validation Program at the Arranta Bio Gainesville site, including developing validation protocols and summary reports (IQ,OQ,PQ). to ensure compliance with regulatory agency requirements, internal company standards and current industry practices.

ESSENTIAL JOB FUNCTIONS

• Generate and execute validation protocols (IQ/OQ/PQ) of equipment including production equipment, utilities (as applicable) and other related systems
• Author or update validation SOPs
• Perform hands on execution of IQ,OQ, PQ for equipment, facilities, utilities, as well as cleaning, and manufacturing processes in accordance with predefined test protocols
• Create and support Change Control documentation for validation, analytical, equipment changes.
• Maintain the site validation master plan and revise as required.
• Identify validation gaps and remediate as necessary.
• Resolve all deviations and non-conformances reported during validation/qualification
• Analyze validation results and compile data into summary reports for initial qualifications and re-qualifications
• Coordinate testing schedule with impacted area managers and quality control based on project needs
• Investigate and troubleshoot validation problems
• Participate in equipment failure investigations, corrective/preventive actions and equipment release
• Contribute to the successful completion of project milestones and crucial technical tasks
• Review of change control, SOP's, calibration, preventative and corrective maintenance documentation for equipment/system to assure that all remain in a validated state

KEY CHARACTERISTICS

Experience and Skills

• Requires Bachelor's degree, preferably in Engineering.
• Five (5) years in a CGMP-related industry with at least one three (3) years in validation of equipment, utility, and process in a GMP regulated environment.
• Strongly prefer candidates with experience with investigating and troubleshooting validation problems
• Prefer validation experience in microbial fermentation and oral solid dosage equipment
• Must have the ability to work successfully on cross functional teams, excellent written and verbal communication, meet deadlines, and successfully work under pressure in a fast-paced environment
• The successful candidate will be energetic and technically sound, with strong interpersonal skills.

PHYSICAL DEMANDS

• While performing the duties of this job, the employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear.
• The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl.
• The employee must frequently lift and/or move up to 20 pounds and occasionally lift and/or move up to 50 pounds.
• Specific vision abilities required by this job include close vision, and ability to adjust focus.
• No travel required.
• Communicate using telephone and e-mail.

BENEFITS

Arranta Bio is an Equal Opportunity Employer.