Talent.com
August Bioservices
Validation SupervisorAugust Bioservices • Nashville, TN, United States
No longer accepting applications
Validation Supervisor

Validation Supervisor

August Bioservices • Nashville, TN, United States
30+ days ago
Job type
  • Full-time
Job description

Validation Supervisor

Reporting to the Senior Director of Validation and Metrology, the Validation Supervisor will be responsible for providing leadership and guidance in validation-related tasks to the validation team with up to 5 direct reports. The Supervisor independently directs and performs validation tasks to meet customer needs and comply with cGMPs. The supervisor will manage validation projects and serve on validation project committees. Develop Validation Master Plans and provide guidance for best validation practices. The supervisor will also represent the Validation Department on interdisciplinary facility teams and client meetings/visits. The Supervisor will be considered a subject-matter expert in certain validation methods and practices and will represent August Bio in both agency and customer audits.

Responsibilities

  • Maintain the validation team project schedule.
  • Tracks the progress and success of their direct reports.
  • Helps to develop goals for direct reports.
  • Write Validation Master plans and all other validation protocols, including IOQ's, PQ's, final reports, and SOPs.
  • Manage the qualification and re-qualification schedule.
  • Provide reviews and oversight to validation reports and periodic reviews.
  • Provide training for both internal and contract personnel.
  • Proactively identifies potential obstacles to successful project completion and helps establish remediation for them.
  • Develops Validation acceptance criteria.
  • Provides leadership in the field and executes validations in the field.
  • Provides acceptance criteria based on agency guidelines and best practices.
  • Recommends validation procedural and test improvements.
  • Review equipment drawings and facility P&IDs from a validation perspective.
  • Manages resource support for validation projects
  • Schedule and chair interdepartmental project meetings
  • Participates as a validation representative on failure investigation teams.
  • Represent August Bio as validation SME for agency and customer audits

Qualifications

  • Excellent verbal and written communication skills
  • BS in Biology, Biochemistry, Microbiology, or Chemical Engineering
  • 6+ years of Validation experience in Pharmaceutical, Biological or Biotech industry
  • Experience managing a team, or significant experience coaching and mentoring team members

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Prolonged periods sitting at a desk and working on a computer.
  • Must be able to lift up to 50 pounds at times, and up to 30 pounds frequently.

August Bioservices is an equal opportunity employer and values diversity. All aspects of employment, including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. August Bioservices does not discriminate on the basis of any status protected under federal, state, or local law.

Create a job alert for this search

Validation Supervisor • Nashville, TN, United States

Similar jobs

Medical Billing and Coding - Entry Level Training Program

Dreambound Inc.Hendersonville, Tennessee, US
Full-time

Note : This is an educational program, not a job.Successful completion of the program does not guarantee employment but will equip you with valuable skills for the healthcare job market.Looking to ... Show more

 • Promoted

Shift Supervisor

Open Arms CareAntioch, TN, United States
Full-time

Join a team that truly makes a difference-helping people with intellectual and developmental disabilities live their best lives today!BENEFITS OF JOINING TEAM OAC:Personal satisfaction from serving... Show more

 • Promoted

Food Supervisor

SodexoNASHVILLE, TN, US
$18.00 hourly
Full-time

LIPSCOMB UNIVERSITY - 54156020.Varying shifts, days/hours (open availability preferred).More details will be provided during the interview process.University students with restrictions on number of... Show more

Field Supervisor

AWP SafetyNashville, TN, United States
Full-time

AWP Safety is North America's leading traffic control specialist.Our team of 9000+ professionals helps secure 2,000+ work zones every day ensuring customer crews, drivers, and our teams get home s... Show more

 • Promoted

Supervisor

Captain D'sNashville, TN, United States
Full-time

As the supervisor, you'll be the go to person during the shift - the first in line to resolve issues and quick to lend a helping hand where needed.When the manager is not present, you'll be respons... Show more

 • Promoted

Senior Operations Supervisor

Burlington Stores, Inc.Nashville, TN, United States
Full-time

The Senior Operations Supervisor is the store's strategic owner of freight receiving, processing, replenishment, and BOH workforce planning.This leader is accountable for key performance indicators... Show more

 • Promoted

Clinical Supervisor - LPC, LMFT, LCSW

Behavioral Health GroupNashville, TN, United States
Full-time

Clinical Supervisor - LPC, LMFT, LCSWJob SummaryThe Clinical Supervisor provides clinical supervision to internal counselors pursuing their Licensed Alcohol and Drug Abuse Counselor (LADAC) credent... Show more

 • Promoted

Order Verification Specialist

Renewal by AndersenNashville, TN, United States
Full-time

Order Verification SpecialistRenewal by Andersen-Nashville, TNRenewal by Andersen is the custom division of Andersen Windows.Founded in 1903, Andersen Windows has been the world's largest and most ... Show more

 • Promoted

Physical Flows Supervisor

ValeoSmyrna, TN, United States
Full-time +1

Valeo is a tech global company, designing breakthrough solutions to reinvent the mobility.We are an automotive supplier partner to automakers and new mobility actors worldwide.Our vision? Invent a ... Show more

 • Promoted

Manufacturing Supervisor

Nice Pak ProductsSmyrna, TN, United States
Full-time

POSITION Summary: This position will have responsibility for the implementation and execution of the lean transformation process thru the use of lean tools.OEE, standard work process, value added s... Show more

 • Promoted

Supervisor Delivery NFS

Coca-Cola Bottling CoLa Vergne, TN, United States
Full-time

Requisition ID:245230Locations:LaVergnePay Range:$60,000.Salaried, depending on experienceSchedule:(Open Field)Click here to experience a Day in the Life of our Teammates!Uncap Your Potential at Am... Show more

 • Promoted

Supervisor Warehouse Operations

AloricaLa Vergne, TN, United States
Full-time +1

Supervisor Warehouse Operations.At Alorica, we only do one thing make lives better, one interaction at a time.We're a global leader in customer service and experience, serving the world's biggest ... Show more

 • Promoted

Shift Supervisor

K1 SpeedNashville, TN, United States
Full-time

Do you have the need for speed? Do you thrive in a fast paced, energetic work environment that focuses on serving our customers? If so, K1 Speed is the place for you.As the nation's indoor electric... Show more

 • Promoted

Warehouse Returns Supervisor

SolotechAntioch, TN, United States
Full-time

Warehouse Returns SupervisorSolotech is not accepting Agency/Recruiter submissions.To take your career to the next level! As a global leader in live productions, systems integration and virtual tec... Show more

 • Promoted

Food Service Supervisor

TKC Holdings, Inc.Nashville, TN, United States
Full-time

OverviewAre you looking for a career with premium benefits and the potential for growth? At Trinity Services Group, we have created something special, a better place to work and grow.Many employees... Show more

 • Promoted

Supervisor

Popeyes Louisiana Kitchen IncNashville, TN, United States
Full-time

As the supervisor, you'll be the go to person during the shift - the first in line to resolve issues and quick to lend a helping hand where needed.When the manager is not present, you'll be respons... Show more

 • Promoted

Quality Assurance Supervisor

AssurantMount Juliet, TN, United States
Full-time

This role is responsible for supervising the completion of and/or completing the Quality Assurance audits on relevant shifts at the DCC; Quality audits cover all areas of the DCC.You will also be r... Show more

 • Promoted

System Test and Validation Lead

DeloitteHermitage, TN, United States
Full-time

Deloitte is committed to providing reasonable accommodations for people with disabilities.If you require a reasonable accommodation to participate in the recruiting process, please direct your inqu... Show more

 • Promoted

Shift Supervisor F&B

Paradies LagardereNashville, TN, United States
Full-time

Are you a coffee enthusiast with a flair for leadership? Do you thrive in a fast-paced and customer-centric environment? Join us at Bongo Java as a Supervisor and be part of a coffeehouse chain tha... Show more

 • Promoted

Supervisor

Marco's PizzaNashville, TN, United States
Full-time

As the supervisor, you'll be the go to person during the shift - the first in line to resolve issues and quick to lend a helping hand where needed.When the manager is not present, you'll be respons... Show more