Summary:
This individual is responsible for performing tasks related to Process Validation (PV) activities, as well as general PV support, with supervisory direction. The individual performs a variety of routine work within established policies and procedures, and receives detailed instructions on new projects and assignments. The individual is expected to have the knowledge and aptitude to perform routine assignments and is expected to independently solve problems or collaborate to solve the problem to the best of their ability. Questions on tasks or issues will be raised by this individual when clarification or greater technical expertise is required.

Job Duties:
* Able to work with minimal assistance and supervision on basic PV techniques of protocol development, execution, and reporting to ensure technical content is sufficient and accurate.
* Make protocol decisions (i.e. conclusions, product impact / validation impact assessment, corrective actions) without review of a higher-level PV scientist or Manager. Understands the role of specifications, acceptance criteria, and sample plans within PV protocols and is able to escalate the appropriate quality system response, as required.
* Knowledgeable of disciplines including standard industry guidance and in depth understanding of the intent and philosophy of the validation exercise.
* Note: This includes, but is not limited to, the following PV Activities:
o Process Validation Plan (PVP) Generation, Process Performance Qualification (PPQ), Large Scale Resin Lifetime, Ultrafiltration Filtration (UF) Membrane Lifetime, Media and Buffer Mixing, Media Pre-Filtration, Impurity Clearance, Intermediate Microbial Hold, Reprocessing/ Refiltration, Bioprocess Container (BPC) Hold, Continued Process Validation (CPV), and Periodic Quality Review (PQR).
o Discrepancies/ Exceptions: Able to generate process validation discrepancies/ exceptions for investigations to ensure root cause, process/validation impact, and corrective actions are accurate.
o Change Management: Qualified to perform process change control assessments.
o Deviations: Able to assist on deviations and provide guidance on validation impact with minimal assistance.
o CAPA: Able to generate process validation Corrective Actions Preventative Actions.
o SOPs: Author, review, and revise PV Standard Operating Procedures independently.
* Represents PV on internal and external project teams. Interfaces with customer technical and quality representatives on study related work. Provides regular updates on study related progress.
* Facilitates inspection readiness, seeks development opportunities for agency inspections and audits to include backroom and front room support with supervision, as required.
* Follows all training and policy guidelines established for the facility as well as all cGMP requirements. Ensures employee training profile is up to date at all times by regular monitoring of training lists (e.g. Cornerstone Learning Portal) and completing all training in a timely fashion.
* Perform other duties as assigned.

Qualifications:
5+ years of biotech industry experience with Bachelors degree, 3+ with Masters degree, 2+ with PhD degree
Strong communication, technical writing, organizational and interpersonal skills; Strong computer skills (including Word, Excel, Outlook, Statistical software, and PowerPoint.)
Demonstrates critical thinking skills in problem solving and decision making; Attention to detail and high level of accuracy; The capacity to motivate and encourage others, in the achievement of specific objectives.

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.