Director, Validation

Harmans, MD, US
Sep 12, 2019
Required Education
Bachelors Degree
Position Type
Full time
Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives.

Paragon Gene Therapy, in Baltimore, Catonsville, Gaithersburg, & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses.

The Director, Validation will have the opportunity to establish and further the Paragon Validation Policy with collaboration from key stakeholders while playing a prominent role in executing site validation strategy and activities. The Director, Validation will provide site specific leadership in validation and is responsible for directing all validation activities for the site, including the qualification of manufacturing equipment/utilities, cleaning processes, manufacturing processes, computer/software, analytical methods, and aseptic/sterile processes.

Key Responsibilities Include, but are not limited to:
  • Development, maintenance and evolvement of the Paragon Validation Program including strategy development (policies and guidance) as well as creating detailed processes and procedures (SOPs).
  • Collaboration with key stakeholders to ensure all aspects of validation are included in the Paragon Validation Program.
  • Providing a growing team structure with guidance and support during ongoing organizational growth. Lead by example exhibiting Paragon values and ensuring teams have the necessary day to day direction and training to execute required activities (ie…qualifications/validation protocols, etc…).
  • Manage external contractor staff, hold them accountable to deliverables according to contracted agreement.
  • Initiation of change controls to determine impact of changes to facility, utilities, equipment, process/product as applicable, and system owners.
  • Investigation of exceptional conditions during the execution of protocols as well as other atypical events, deviations, and non-conformances as required.
  • Abiding by CAPA system by initiating corrective and preventative actions as required and / or contributing to/supporting CAPAs as needed.
  • Training business partners and stakeholders on the Paragon Validation Program.
  • Assure GxP operations are executed in compliance with applicable guidelines and regulations through quality risk management, risk assessment, and auditing functions.
  • Establish and report on key performance indicators, including use of a compliance index, to support quality compliance awareness, initiatives, and resource allocation.
  • Strategy reviewer, from a Validation perspective, of quality system documents including but not limited to CAPA, change controls, investigations, and deviations.
  • Ensures the timely completion of all applicable validation documentation, including coordination of contractor activities.
  • Works closely with management from Manufacturing, QA/QC and Facilities in determining the approach to the execution of validation activities, as applicable.
  • Serves as Validation lead when interacting with clients and/or regulatory bodies.
  • Authors/maintains the cleaning verification master plan and policy.
  • Leads the regulatory defense of validation protocols and summary reports during audits and internal audits.
  • Direct continuous improvement initiatives for the validation of cleaning, aseptic, and manufacturing processes.
  • Provide SME level support to the manufacturing areas as required to assist in problem solving and long-term changes that provide product/process improvements in relation to process failures.
  • Participate in product failure investigations.
  • Build and maintain successful cross-functional relationships with internal customers such as Manufacturing, Process Development, Analytical, Quality and Facilities Engineering.
  • Maintain up to date knowledge of validation requirements, practices, and procedures and instruct other members of the site participating in validation studies.
  • Ability and willingness to work in a fast-paced environment.
  • Performs duties related to Corrective and Preventative Action (CAPA) plans, deviations and change control.
  • Prepares summary, deficiency and discrepancy reports, gap analysis, risk analysis and FMEA.
  • Budgetary input for organization, including preparation, maintenance, and re-forecasting.
  • Other duties as assigned.

Skills & Abilities
  • Requires experience and a good understanding of the processes used in a GMP biopharma manufacturing facility.
  • Has demonstrated track record for executing (hands-on) validation activities in a GMP biopharma facility.
  • Has good working knowledge of the regulatory requirements (FDA, EMEA) for biopharma processes and cleaning.
  • Working knowledge of study design to support process characterization, including column/resin lifetime studies.
  • Direct experience developing validation protocols and execution of protocols in support of a successful Performance Process Qualification (PPQ) campaign.
  • Knowledge of current industry standards surrounding the development of a manufacturing process control strategy, process Failure Modes & Effects Analysis (FMEA), and Scaledown Model Qualifications.
  • Strategic thinker with experience working with customers developing testing, validation and/or quality strategies.
  • Excellent communication skills.

Education & Experience:
  • Bachelor degree in Engineering or Science field.
  • 15 or more years of experience in biopharma Validation/Quality role.
  • 8 or more years in a supervisory/management role.
  • Experience with designing and leading a successful Performance Process Qualification (PPQ) campaign is highly desirable.
  • Experience in designing and leading Aseptic Process Simulations is highly desirable.
  • Leading the design/execution of an equipment cleaning validation study, to include working knowledge of setting cleaning limits and swab recovery studies

    Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.