Shire Sr Expert, PV CA or MA in Westlake Village, California
The PV Senior Expert
Represents the PV-Strategy group in project teams and interfaces with peers in various other departments such as Process Development /Technical Services, Engineering, Quality, Validation and Manufacturing as well as with CMOs.
Acts as an expert within the Process Validation discipline.
Receives assignments in form of objectives and establishes goals to meet objectives. Work is reviewed and measured based on meeting objectives and schedules.
Is responsible for the development and implementation of process validation strategies for PDTS CMC programs. Ensures that the PV strategy of manufacturing processes meets regulatory agency requirements, internal company standards and current industry practices.
Is responsible for the development and/or review of necessary PV documentation including PV Strategy Dossier or Process Validation Master Plan, protocols, reports and related regulatory filing sections.
Provides process validation expertise and recommendations for major/critical process deviations.
Contributes to the implementation of Shire’s process validation program through the successful integration of QbD elements in process and product development
Establishes and recommends changes to procedures which effect subordinate organizations. Executes systems, standards and guidelines
Proactively monitor innovative and purpose driven improvement within own area of expertise
Support decisions within the area of responsibility
Coaches other professionals (e.g. PPQ-, CPV-teams)
The challenge of this position is to balance increasing regulatory requirements and expectations for Process Validation against business needs. This can only be achieved by trying to see the big picture, understanding the value-added of the lifecycle approach to Process Validation and using critical and risk-based thinking.
This position Impacts quality of own work and of others in the team.
LOCATION: Open to Los Angeles, CA, Thousand Oaks, CA or Lexington, MA
Describe the essential job duties. After each, provide an estimate of the percent of time typically devoted to each responsibility (use increments of 5%, all time spent should total to 100% of time allocation). To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Please note the percentage of time spent on each job duty is an estimate for normal operating conditions.
Provide leadership support to PDTS and CMC teams regarding PV strategy and execution for projects with manageable risks and resource requirements. Explain and simplify complex information to others. Lead coordination of information to ensure ongoing program/process execution (15%)
Represent function globally or in cross-functional programs/ projects/processes. (5%).
QbD/PV related strategic tasks (Shire and CMO) (80%)
Develop, review and/or approve PV Strategy Dossiers and other documentation relative to PV activities (PPQ protocols and reports, comparability protocols, consolidated validation reports, regulatory submission documents, etc.); provide technical support in case of critical process-related deviations in terms of root cause investigation and implementation of corrective and preventive actions (25%).
Provide guidance in regards to the development and definition of PV and Control strategies (e.g. number/kind of studies, small scale vs. large scale, number of lots, test program & limits) in various stages of the product life cycle; support facilitation of manufacturing process related risk assessments; explain and defend the PV and Control Strategy towards internal and external stakeholders (15%).
Lead/facilitate risk assessments of interdiciplinary teams (10%).
Provide major input to process validation strategies for both internal and external (CMO) products (5%).
Support inspections and audits by third parties (e.g. regulatory agencies) and the timely closure of observations/audit items (5%).
Support innovation, continuous improvement and harmonization of workflows, quality systems and procedural guidances in the area of the validation of manufacturing processes (5%).
Maintain and develop expertise in process validation e.g. through trainings, literature review, participation in industry associations and workgroups and by adopting sensible and approved concepts (10%).
Contribute to monthly PV related forums and workshops (5%)
Education & Experience Requirements
University degree (BS/MS/PhD) in life sciences like biotechnology, biochemistry, pharmacy, process engineering or equivalent.
Minimum of 5 years of professional experience in industry environment of an internationally operating company recommended – ideally at least half of them in pharma industry
Strong working knowledge and expertise in the area of Process Validation and QbD
Experience in the management of small and medium projects
Knowledge of and appropriate compliance with guidelines as well as Shire internal requirements
Basic experience in interacting with regulatory authorities and official bodies (FDA, EMA, etc.).
Knowledge of risk assessment tools
Basic Statistical education
Strong understanding of biotech/plasma products and processes
Key Skills and Competencies
Describe critical skills needed to successfully perform the job, which should be representative of the knowledge, skills and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Living our leadership behaviors is a basic expectation for all Shire employees. Shire expects all employees to embody the following:
Be Results Oriented
Be An Excellent Manager of Self and Others
Ability to contribute to global and interdisciplinary teams or to lead smaller teams
Good technical problem solving skills (especially in regard to regulatory demands vs. business
Business acumen, customer orientation and strategic thinking.
High degree of internal/external customer sensitivity/acumen
Uncompromised dedication to quality.
Ability to provide risk based assessments and /or recommendations for business critical decisions or documents – and to identify ‘must haves’, ‘preferences’ and ‘nice to haves’.
Cultural awareness when dealing with employees/partners/customers/regulators with different cultural background.
Strong written and verbal communication skills. English fluently both in spoken and written language
Quick perception, analytical and abstract reasoning, solution oriented thinking
Demonstrated ability to work collaboratively with others and in a cross-functional team environment
Personal attributes: integrity and trust, work ethic, courage, personal accountability for results, curiosity and passion for results.
Digital competencies, experience with project management tools.
Ability to cope with pressure (flexibility in regard to changing demands)
Other Job Components
Complexity and Problem Solving
Takes decisions (in close consultation with supervisor) on:
Process validation strategies
Communication contents, paths and time points with internal stakeholders,
Works on problems of moderate scope in which analysis of situation or data requires evaluation of identifiable factors
Acts as advisor to units or sub-units, becomes actively involved as required to meet schedules or resolve problems with minor business impact (where precedent may not exist)
Erroneous decisions or failure to achieve results will cause delays in schedules.
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Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.