Director, Validation

2 months ago

Weston, United States Transpire Bio Full time

Job Summary

The Director - Validation independently prepares, reviews, and executes high quality, Qualification, Validation and Reports within company timelines and following regulatory guidelines and applicable laws. The incumbent will oversee all qualification/validation related work with respect to facility and processes as it pertains to a cGMP facility. They will manage, mentor and train junior staff to support on-going operations.


Essential Functions

The incumbent will function as the Subject Matter Expert (SME) for the validation policy within the company. Focusing on Equipment, Facilities and Cleaning Validation, the incumbent will oversee, as well as develop and execute validation protocols associated with the installation, operation and performance qualification and requalification of equipment, utilities and processes used in the manufacture of aseptically/non-aseptically produced inhalation products.

  • The SME will provide technical expertise during design, evaluation and procurement of new equipment, utilities, or processes.
  • Incumbent will develop and maintain a Validation Master Plan (VMP)
  • Generate and maintain life cycle documentation for equipment and systems, including User Requirements Specifications, Functional Specifications, Hardware Design Specifications, Software Design Specifications, and Configuration Specifications.
  • Support all aspects of the Validation Life Cycle, from design through operation and improvement.
  • Plan, coordinate and manage site-specific validation project activities including protocol development/approval, work schedules and lifecycle documentation.
  • Review qualification/requalification packages for completeness and accuracy, sound rationale, compliance with validation policies and procedures and accurate data analysis.
  • Provide and document training to personnel performing validation activities.
  • Provide the technical input to address validation deviations and provide assessments for change requests and identify qualification requirements to ensure compliance to GMP’s and that the validated state is maintained.
  • Coordinate protocol approvals and produce accurate summary reports.
  • Develop or contribute to the development of SOPs related to equipment or processes for which the incumbent serves as SME.
  • Remain current with FDA guidance’s and requirements regarding the validation of aseptic/non-aseptic manufacturing processes; ensures all work is performed and documented following existing Company policies and procedures, as well as cGMP and health and safety requirements.
  • Interface with Quality and Manufacturing groups to facilitate and drive validation execution and completion.


  • Additional Responsibilities
  • Ability to read/interpret engineering drawings and design documents.
  • Ability to manage multiple projects at a time.
  • Strong knowledge of MS-Office software and PC Skills required.
  • Good technical writing skills.
  • Excellent communication, problem-solving, planning and organization skills.
  • Ability to work independently, including making sound decisions and managing priorities that are in alignment with site and company directives.
  • Ability to mentor and direct junior team members.
  • Ability to work within a team-oriented environment.
  • Ability to work off hours and weekends.


Education

  • Bachelor’s Degree (BA/BS) in Life Sciences, Engineering, Technical, or equivalent work experience
  • 10+ years of pharmaceutical industry with 5+ years of GMP; new facility start-up experience preferred.


Skills And Abilities

  • Time management, organization and planning skills, multi-tasking and prioritization skills in a fast-paced environment are required.
  • Ability to maintain a high level of accuracy and attention to detail, while meeting deadlines for assigned projects.
  • Excellent written and verbal communication skills and interpersonal skills.
  • Ability to communicate effectively and collaboratively as part of a team in a respectful manner.
  • Ability to work independently, self-starter.
  • Good problem-solving skills and analytical ability.
  • Specialized Knowledge
  • Strong knowledge and understanding of cGMP regulations and practices pertaining to validation principles, manufacturing processes, quality systems, engineering design fundamentals, regulatory agency expectations and industry trends.

  • Associate Director, Government Pricing

    2 weeks ago

    Weston, United States Apotex Corp. Full time

    As Associate Director, Government Pricing, you will be responsible to lead the Pricing team in validation, calculation, and analytics to ensure compliance and integrity, along with insights to enable good business decisions. Responsible for maintaining compliance with all government pricing calculations and reporting along with interpretation of statutes,...

  • Associate Director, Government Pricing

    2 weeks ago

    Weston, United States Apotex Corp. Full time

    As Associate Director, Government Pricing, you will be responsible to lead the Pricing team in validation, calculation, and analytics to ensure compliance and integrity, along with insights to enable good business decisions. Responsible for maintaining compliance with all government pricing calculations and reporting along with interpretation of statutes,...

  • Funeral Service Professional

    4 weeks ago

    Weston, Massachusetts, United States Gpac Full time

    Funeral Director and Embalmer OpportunityA reputable firm is seeking a skilled Funeral Director and Embalmer to join their team. This role offers a unique chance to work in a community-focused environment and provide compassionate support to families in need.Key Responsibilities:Direct and embalm funerals with precision and careDevelop and implement funeral...

  • Respiratory Therapist

    4 weeks ago

    Weston, United States Mon Health Full time

    Job SummaryAs a Respiratory Therapist at Mon Health, you will work under the direction of the Director of Respiratory Therapy and/or the Medical Director to set up and operate various types of respiratory care equipment for the diagnosis and treatment of respiratory disease and/or illness in patients of all ages.Position...

  • Funeral Service Professional

    2 months ago

    Weston, Massachusetts, United States Gpac Full time

    Funeral Director and Embalmer OpportunityWe are seeking a skilled and compassionate Funeral Director and Embalmer to join our team. As a Funeral Director and Embalmer, you will be responsible for providing exceptional care and support to families during their time of need.Key Responsibilities:Direct and coordinate funeral services, ensuring that all details...

  • Pharmacy Assistant

    3 weeks ago

    Weston, United States Mon Health Full time

    Job SummaryAt Mon Health, we are seeking a skilled Pharmacy Technician to provide accurate and prompt assistance in filling and stocking automated dispensing machines. The successful candidate will work under the direct supervision of the Director of Pharmacy and Pharmacists, maintaining medication inventory throughout the hospital.Key ResponsibilitiesAssist...

  • Accounts Payable Director

    4 weeks ago

    Weston, United States Phoenix Pro Connect Full time

    Accounts Payable ManagerPhoenix Pro Connect is seeking an experienced Accounts Payable Manager to lead our financial operations team.Key Responsibilities:Direct and manage daily activities of the accounts payable department.Efficiently process high-volume transactions, handling over 2,000 bi-weekly invoices.Utilize and optimize the COR360 platform to ensure...

  • Pharmacy Assistant

    3 weeks ago

    Weston, United States Mon Health Full time

    Job SummaryAt Mon Health, we are seeking a highly skilled Pharmacy Technician to provide accurate and prompt assistance in filling and stocking automated dispensing machines. The successful candidate will work under the direct supervision of the Director of Pharmacy and Pharmacists, maintaining medication inventory throughout the hospital.Key...

  • School Nurse Position

    4 weeks ago

    Weston, Massachusetts, United States Marathon Staffing Full time

    Job OpportunityMarathon Staffing is seeking a reliable and compassionate Registered Nurse to provide exceptional nursing care to students and staff in a school setting.Responsibilities include:Promoting a culture of respect and inclusionDelivering nursing care to students and staffAdministering medications and prescribed medical treatmentsWorking with...

  • Director, Analytical Development/Analytical Sciences

    1 month ago

    Weston, United States Transpire Bio Full time

    SummaryProvides subject matter expertise on all topics Analytical Sciences. Provides scientific and technical leadership in identification, selection and implementation of analytical techniques that may be suitable for the portfolio of projects. Develops and oversees strategies for development, verification, optimization, transfer, and validation of stage...

  • Director, Analytical Development/Analytical Sciences

    2 months ago

    Weston, United States Transpire Bio Full time

    SummaryProvides subject matter expertise on all topics Analytical Sciences. Provides scientific and technical leadership in identification, selection and implementation of analytical techniques that may be suitable for the portfolio of projects. Develops and oversees strategies for development, verification, optimization, transfer, and validation of stage...

  • Special Education Teacher Position at Robert L. Bland Middle School

    4 weeks ago

    Weston, United States West Virginia Department of Education Full time

    Job Title: Special Education TeacherWe are seeking a qualified Special Education Teacher to join our team at Robert L. Bland Middle School. The successful candidate will be responsible for teaching students with special needs and providing individualized support to ensure their academic and personal growth.Job Summary:The Special Education Teacher will be...

  • School Nurse

    4 weeks ago

    Weston, Massachusetts, United States Marathon Staffing Full time

    Job OpportunityWe are seeking a reliable and compassionate Registered Nurse to join our team as a School Nurse. This per diem position is available immediately in Weston, MA.Key Responsibilities:Promote a culture of respect and inclusion in the school system.Deliver exceptional nursing care to students and staff, ensuring their health and...

  • Itinerant Physical Education Specialist

    4 weeks ago

    Weston, West Virginia, United States West Virginia Department of Education Full time

    Job Summary:We are seeking a highly qualified and experienced Itinerant Physical Education Teacher to join our team. The successful candidate will be responsible for teaching physical education to elementary school students, promoting physical activity and healthy lifestyles, and developing and implementing curriculum to meet the needs of our...

  • Wellness Nurse

    2 weeks ago

    Weston, United States Maplewood Senior Full time

    Wellness Nurses Shift Available: Per DiemStarting Wage: $40/hourMaplewood at Weston, 99 Norumbega Rd, Weston, MA Want to know what makes our employees eager about going to work every day? The people we serve. Being a part of Maplewood requires passion and a desire to help others. Each employee has the ability to touch the hearts of all our seniors and be a...

  • Public Health Nurse- COVID Full Time

    4 weeks ago

    Weston, MA, United States Maplewood at Weston LLC Full time

    Wellness Nurses  Shift Available: Per Diem Starting Wage: $40/hour Maplewood at Weston, 99 Norumbega Rd, Weston, MA Want to know what makes our employees eager about going to work every day? The people we serve. Being a part of Maplewood requires passion and a desire to help others. Each employee has the ability to touch the hearts of all our seniors...