See more Collapse

Validation Manager

3 months ago

Lenoir, United States Exela Pharma Sciences Full time
Position Summary:

Oversee and lead the validation program for production equipment and processes used to support manufacturing of aseptic and terminally sterilized products. Lead the validation team in the establishment and maintenance of validated systems. Coordinate technology transfer activities in support of commercialization. Serve as a technical resource to improve product quality, reliability, and process capability. Support manufacturing to satisfy the quality and process validation requirements for existing products. Participate in the development and validation of new products, as needed.

Job Responsibilities:
  • Plan, perform and coordinate validation projects to ensure timely completion
  • Responsible for drafting and providing technical guidance for the validation program, Policies and SOPs and other master documents
  • Support Engineering and Manufacturing in the development of critical process parameters and provide technical leadership for deviation investigations
  • Analyze data to provide recommendations for improvements in the manufacturing process and equipment
  • Assess new and existing processes (including Equipment IOPQ, Process, etc.) against cGMP and requirements for validation
  • Develop and implement strategies for equipment IQ/OQ/PQ, process validation, computer system validation and calibration
  • Perform functional and process risk assessments in conjunction with Quality and Manufacturing subject matter experts
  • Oversee development and execution of validation protocols and review objective evidence for inclusion in validation reports
  • Assist with the technical assessment and resolution of deviances and variances that occur during production or validation
  • Work with Quality, Manufacturing, Regulatory, and subject matter experts to prepare for FDA and other agency audits
  • Ensure site/system validation program meets FDA, ISO and EU requirements
  • Collaborate with peers and stakeholders to in QA and Manufacturing to identify opportunities for process improvement
  • Facilitate communication and implementation of consistent processes across various product teams and global manufacturing sites
  • Provide updates to Senior Management on site validation status activities
  • Provide validation training to staff on validation protocols and standard operating procedures
  • Support investigations and implementation of CAPAs, as needed
  • Perform any other duties assigned
Required Skills:
  • Must have exceptionally strong communication, interpersonal and project management skills
  • Ability to multi-task and methodically manage projects in a fast-paced manufacturing environment
  • Ability to lead a team of validation associates to prioritize and manage multiple projects across several product lines
  • Ability to manage consultants and set expectations for the quality and timeliness of their deliverables
Education and Experience Requirements:
  • Bachelors, Masters, or Ph.D. in Biochemistry, Biology, or related science field
  • Demonstrated knowledge and application of FDA cGMP/GCP regulations, ANSI/ISO/IEC/ASQC standards, and 21 CFR Part 11 in a manufacturing setting
  • Demonstrated application of FMEA, Risk Analysis, Validation principles, guidelines, and industry best practice
  • Demonstrated history of team management and effecting cross-functional change with strong analytical problem solving and interpersonal skills
  • Excellent verbal and written communication/documentation skills with a demonstrated ability to clearly present technical topics to a non-technical audience
  • At least 8 years’ experience in the biotech/pharmaceutical industry in validation, quality management, process controls, and continuous improvement in an FDA-regulated environment
  • A minimum of 4 years’ experience with aseptic and terminally sterilized products

EOE, including disability/vets.

We have other current jobs related to this field that you can find below

  • Quality Engineer

    2 weeks ago

    Lenoir, United States Exela Pharma Sciences Full time

    Position Summary: The Quality Engineer will be responsible for providing Quality oversight to the engineering functions at the Company. In this role they assure the company’s Quality Plan is fully implemented by the engineering department for operations, maintenance, and project delivery. The Quality Engineer will assure that cGMPs and regulatory standards...

  • Care Manager

    4 weeks ago

    Lenoir, United States RHA Health Services Full time

    We are hiring for:Care Manager /Sign on bonus $2,500 / Alexander and Caldwell CountyType:RegularIf you are a positive and personable individual looking for a satisfying and fun opportunity to make a real difference in the lives of people with intellectual, developmental disabilities, and people facing mental health, and substance use challenges, join our...

  • Care Manager

    4 weeks ago

    Lenoir, United States RHA Health Services Full time

    We are hiring for: Care Manager /Sign on bonus $2,500 / Alexander and Caldwell County Type: Regular If you are a positive and personable individual looking for a satisfying and fun opportunity to make a real difference in the lives of people with intellectual, developmental disabilities, and people facing mental health, and substance use challenges, join our...

  • NC PK Teacher

    3 months ago

    Lenoir, United States Blue Ridge Community Action Full time

    Job DescriptionJob DescriptionSalary: $19.31Position SummaryResponsible for providing daily classroom activities designed to provide children with a wide variety of developmental experiences.  Duties shall include, but are not limited to, the following:Specific Job DutiesImplement comprehensive curriculum plans with activities appropriate to the age and...

  • Convenience Store Area Supervisor

    6 days ago

    Lenoir, United States Raymer Oil- (Fast Phils, Run In, IGA, FairValue) Full time

    Job DescriptionJob DescriptionDescription:PRIMARY PURPOSE AND MISSION STATEMENT: ROC and its employees pledge to put customers first by:Greeting customers with a friendly smile.Providing quick, accurate, and courteous service.Supplying a variety of products that meet high quantity, quality, and freshness standards.Thanking customers for making us their...

  • Personal Care Assistant

    2 months ago

    Lenoir, United States HCAOA Full time

    For our location in Asheville, we are looking for people who are committed to enhance the quality of life of seniors and people with disabilities by providing the best in-home care with empathy, excellence and integrity. RESPONSIBILITIES As a Caregiver, you will be primarily responsible for providing companionship and assistance with activities of daily...

  • CNA - Home Health

    2 weeks ago

    Lenoir, United States BrightSpring Health Services Full time

    Our Company Adoration Home Health and Hospice Overview Certified Nursing Assistant - CNA  Location: Lenoir, NC Monday- Friday Competitive Pay Rates Mileage Reimbursement Adoration  Home Health is seeking a Home Health Aide - CNA - Certified Nursing Assistant to join our team. This position is a great opportunity to grow your CNA - HHA skillset while...

  • Automotive Sales Specialists

    3 months ago

    Lenoir, United States Friendship Automotive Full time

    At Friendship Automotive, our customers are friends and our Team Members are family.In 5 states and 8 cities with 18 locations, we're looking to add talent to our growing team! Come develop your career with an award-winning, customer-focused automotive group. Voted Automotive News BEST DEALERSHIPS TO WORK FOR 12 years and counting!We're looking for SALES...

  • School Counselor

    3 months ago

    Lenoir, United States Caldwell County Schools Full time

    School CounselorSummary Utilizing leadership, advocacy, and collaboration, school counselors promote student success, provide preventive services, and respond to identified student needs by implementing a comprehensive school counseling program that addresses academic, career, and personal/social development for all students. The major functions of the...

  • Foreman

    2 weeks ago

    Lenoir, United States Turner Construction Full time

    Division: Carolinas Project Location(s): Lenoir, NC 28633 USA Minimum Years Experience: Travel Involved: Job Type: Regular Job Classification: Trade Education: Job Family: Trade Compensation: Non-Union Trade Position Description: Lead, direct, and coordinate work of Turner Trade employees, subcontractors, and/or vendors. Manage schedule delivery, quality...

  • Maintenance Technician

    3 weeks ago

    Lenoir, United States NPS Holdings LLC Full time

    Job DescriptionJob DescriptionCompany ProfileNPS was founded in 1996 in Green Bay, Wisconsin.  We are committed to providing high-quality products, responsive service and exceptional value. With multiple locations across the United States, NPS makes towel and tissue products for the Away from Home markets in addition to specialty packaging material (both...

  • Maintenance Technician

    3 weeks ago

    Lenoir, United States NPS Holdings LLC Full time

    Job DescriptionJob DescriptionCompany ProfileNPS was founded in 1996 in Green Bay, Wisconsin.  We are committed to providing high-quality products, responsive service and exceptional value. With multiple locations across the United States, NPS makes towel and tissue products for the Away from Home markets in addition to specialty packaging material (both...

  • Mortgage Field Services Inspector

    4 weeks ago

    Lenoir, United States Far Inspections Full time

    Job DescriptionJob DescriptionFAR Inspections is looking for highly motivated individuals to perform residential occupancy verifications on behalf of mortgage lenders.Independent contractors earn predictable full-time or supplemental income and enjoy a flexible schedule. Experience with mortgage field inspections is not required but an ability to...

  • Mortgage Field Services Inspector

    4 weeks ago

    Lenoir, United States Far Inspections Full time

    Job DescriptionJob DescriptionFAR Inspections is looking for highly motivated individuals to perform residential occupancy verifications on behalf of mortgage lenders.Independent contractors earn predictable full-time or supplemental income and enjoy a flexible schedule. Experience with mortgage field inspections is not required but an ability to...

  • Foreman

    4 weeks ago

    Lenoir, United States Turner Construction Full time

    Division: Carolinas Project Location(s): Lenoir, NC 28633 USA Minimum Years Experience: Travel Involved: Job Type: Regular Job Classification: Trade Education: Job Family: Trade Compensation: Non-Union Trade Position Description: Lead, direct, and coordinate work of Turner Trade employees, subcontractors, and/or vendors. Manage schedule delivery, quality of...

  • Foreman

    2 weeks ago

    Lenoir, United States Turner Construction Full time

    Division: Carolinas Project Location(s): Lenoir, NC 28633 USA Minimum Years Experience: Travel Involved: Job Type: Regular Job Classification: Trade Education: Job Family: Trade Compensation: Non-Union Trade Position Description: Lead, direct, and coordinate work of Turner Trade employees, subcontractors, and/or vendors. Manage schedule delivery, quality of...

  • Physical Therapist I

    3 weeks ago

    Lenoir, United States UNC Health Full time

    Become part of an inclusive organization with over 40,000 diverse employees, whose mission is to improve the health and well-being of the unique communities we serve. Summary: This is professional level work involving the evidence- based evaluation of patient disabilities, planning, and administration of physical therapy treatments. Incumbents complete...

  • Delivery Driver

    2 months ago

    Lenoir, United States Domino's Franchise Full time

    Job DescriptionJob DescriptionCompany DescriptionPrairie Pizza is a family-owned Domino's franchise based out of Charlotte, NC.  Our three basic principles are Golden Rule, Teamwork, and Enthusiasm.  We pride ourselves on being the #1 pizza brand in the Charlotte and Raleigh markets.Our employees love working for us because they enjoy being part of...

  • Physical Therapist I

    3 weeks ago

    Lenoir, United States UNC Health Care Full time

    Description Become part of an inclusive organization with over 40,000 diverse employees, whose mission is to improve the health and well-being of the unique communities we serve. Summary: This is professional level work involving the evidence- based evaluation of patient disabilities, planning, and administration of physical therapy treatments. Incumbents...

  • Physical Therapist I

    6 days ago

    Lenoir, United States UNC Health Care Full time

    Job DescriptionDescriptionBecome part of an inclusive organization with over 40,000 diverse employees, whose mission is to improve the health and well-being of the unique communities we serve.Summary:This is professional level work involving the evidence- based evaluation of patient disabilities, planning, and administration of physical therapy treatments....