Validation Associate

Desired Skills: process validation,GMP,project management

The role:

PE Global is currently recruiting for a Process Validation Associate on behalf of a leading pharmaceutical company based in Cork. This is an initial 12 month contract.

Job Description:

This position reports to the Process Validation Manager and is responsible for multi-modality process validation activities in a cGMP environment. 

This position will coordinate and manage process validation projects related to the implementation of new manufacturing processes and changes to existing processes according to the three phases of process validation.  Process validation activities may include drug substance manufacturing processes, drug product filling processes and completion of validation risk/impact assessments and evaluations, etc.

The position organizes and performs process validation activities with general supervision within a cross-functional cGMP environment while fostering a collaborative Team environment. 

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 company and 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, validation techniques/approaches and systems
• 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.

Education and Experience:

• 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
• 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.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***