Validation Specialist (Onsite) Location: Swiftwater, Pennsylvania

Ability to write process validation documents and execute

Process performance qualification skills required

Manager does not want computer validation related roles, Must have manufacturing on the floor experience, collect process samples

Must gown up for role and best GMP practices

Proficiency in Pi is a plus

MANAGER NOTES:

Process Validation
Proficient in MS Office
Strong communication, proficient in English written and verbal
Ability to write process validation documents and execute
Process performance qualification skills required
Manager does not want computer validation related roles, Must have manufacturing on the floor experience, collect process samples
Must gown up for role and best GMP practices
Proficiency in Pi is a plus
Previous micro fluidizer experience
VALIDATION SPECIALIST

Accountabilities:

Key contributor for strategy development and execution of development and process validation related to adjuvant manufacture. Provides input to industrialization strategies and rationale for critical process parameters. Subject Matter Expert (SME) for development and validation, and investigations. The individual in this position will work with a cross-functional team from various functions in M&S-V to deliver following:
Support execution of development and validation related studies.
Document and interpret study results with recommendations
Provide technical leadership as an subject matter expert in multiple areas of responsibility
Develop and execution of training programs for appropriate audiences
Comply with cGMP and other internal and external quality and regulatory guidance and health and safety guidelines.
Assist with assessing existing processes and workflows.
Translate processes to commercial operations.
Ownership of equipment unit operations and technology capabilities.
Communicates findings and proposals to upper management.
Improve Manufacturing Technology strategic programs by supporting non-conformance issues related to change controls, deviations, corrective and preventative actions (CAPAs).
Participate in Gemba/ shop floor walk through to learn about production processes and / or interview stakeholders to collect data for continuous improvement of strategic programs and development of validation strategies/documents.
Develop and update standard operating procedures and related technical documents to align to program strategies under a cGMP environment.
Work closely with other members of the department to share knowledge and competencies encouraging individual growth and technical contributor.

Responsibilities:

Write protocols, reports, procedures and memos as needed to support Adjuvant manufacturing activities related to engineering, investigational, definition, development and process validation runs
Support execution and documentation of engineering, development and/or validation studies and lead or supervise groups and/task force in the planning of engineering, investigational, definition, development and process validation runs.
Input to design space / DOE studies through establishment of scale-up / scale-down parameters utilizing engineering fundamentals (mixing, mass / heat transfer, modeling, dimensionless parameters, etc.) and process control strategies.
Provide technical assistance to manufacturing and quality operations for process troubleshooting, improvement, technical transfer and health authority inspections to achieving site metrics (+QDCI).
Fosters relationships with partners and customers in order to achieve technical objectives.
BS or MS in basic sciences, math, engineering or pharmacy with 2+ years' experience in biological processes or analytics in a cGMP environment.
Proficient with structured methodologies such as Good Engineering Practices, Quality by Design, Design Space, & Process Control Strategies to be employed in the course of industrial process design, validation and control.
Excellent written and oral communication skills.
Ability to work in cross functional teams, provide strong analytical skills for troubleshooting and root cause analysis, and communicate with internal and external team members.
Experience in equipment start-up, qualification and validation is preferred.
Proficiency with PI
Prior experience preparing and executing process performance qualification documents (PPQ) preferred.