Process Validation Engineer

Requirements

Responsibilities:

• Perform process validation activities related to drug substance and drug products through defined clinical and commercial stages.
  
• Execute (protocol generation execution and final package preparation) process validation activities related to the implementation of process changes and new processes while exercising supervised judgment within broadly defined procedures and practices to establish acceptance criteria and to identify and implement solutions to meet Health Authority requirements.
  
• Assist with preparation of regulatory filings with answering questions from regulatory agencies and with presentations of materials during regulatory inspections/partner audits.
  
• Development and implementation of SOPs/Guideline documents with systemic procedural improvements.
  
• Determine methods and procedures on new assignments with supervision and in accordance with developed practices and procedures.
  
• May participate on sub-teams.
  
• Gain/maintain knowledge of industry standards and regulatory requirements for products developed and manufactured by client validation techniques/approaches and systems utilized
  
• Participate in multi-departmental meetings & project teams.
  
• Identifies and assists with implementation of improvements to Process Validation systems (department level impact).
  
• Generation of process validation master plans core validation master plans and additional supporting documentation.
  
• Coordination of process validation activities performed at multiple locations including contract laboratories contract manufacturing/testing facilities and internal laboratories.
  
• Coordination of process validation activities involving cross-functional multi-departmental teams including Manufacturing Technical Development Quality Control Quality Assurance Regulatory Affairs and others.
  
• Other duties as assigned
  

Education:

• Bachelor of Arts/Sciences (BA/BS) degree or higher in a technical discipline (physical engineering chemical or biological sciences) is required.
  
• Training in project management is preferred
  
  

Experience:

• 2 years experience in a cGMP regulated manufacturing environment with exhibited knowledge or proficiency in process validation process sciences and change control.
  
• Organizational and management skills to participate in multi-discipline project groups
  
• Ability to communicate with present data to and defend approaches in front of variable hierarchical audiences scientific disciplines and health authority reviewers/inspectorate.
  
• Ability to comprehend scientific/technical information related to equipment processes and regulatory expectations.
  
• Understanding and demonstrated knowledge of regulatory requirements guidelines and recommendations for process validation expectations.
  
• Proficiency with technical writing expected.
  
• Proficiency with standard office software applications including MS Word MS Excel MS Project MS Power Point. Experience and proficiency with other applications is highly beneficial.
  

Work Environment:

• This function will perform majority of work in an office setting reviewing documents participating in meetings authoring documents. This function may perform up to 60% of its functions at a computer terminal.
  
• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  
• While performing the duties of this job the employee is occasionally exposed to work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals; high pressure and temperature utility systems risk of electrical shock and vibration. The noise level in the work environment is usually moderate.
  
• The ability to perform gowning activities and enter the manufacturing plant is preferred but not required.
  

Equipment:

• This position requires ability to utilize a computer to perform tasks.
  
  

Contacts:

• This position will require interaction with multiple levels (from technicians up through Sr. Management) in Quality Assurance Quality Control Corporate Compliance ManufacturingTechnical Development Facilities Regulatory Affairs and People Resources.
  

Scope:

• The candidate will have a significant role in the approval of documentation and support for release of manufacturing systems and processes for cGMP use. This position is required to successfully complete projects in a timely manner supporting company goals and objectives. Decisions made by this position can significantly affect project timelines and the ability to manufacture drug substance/drug product meeting Health Authority requirements.
  

Supervisor Responsibility:

• Position has no direct reports.
  

Career Development:

• Demonstrated proficiency and experience in developing and maintaining validation department within cGMP expectations for the manufacture of drugs.
  
• Demonstrated proficiency and experience in maintaining and defending validation systems satisfying regulatory inspection scrutiny
  
• Demonstrated proficiency and experience in managing projects requiring multi-departmental coordination.
  
• Demonstrated experience and knowledge of multi-departmental functions and issues (understanding the organization).
  
• Successfully achieving project goals and meeting company deadlines in timely and cost-effective manner.