Validation Engineer Senior
|Job Title:||Validation Engineer Senior|
|Contact Name:||Gerry Kennedy|
|Job Published:||about 5 years ago|
Our client is a fast growing biopharmaceutical company with a newly created role for an experienced validation engineer.
Job Spec :
This position will be part of the EU Quality group responsible for qualification and validation activities related to cold chain/controlled temperature shipments and CMO drug product manufacturing operations in the EU / International regions and will involve;
Working with the cross functional teams in the development and execution of validation activities associated with new equipment / product or system upgrades.
- Developing Validation Documentation (e.g. specifications, plans, protocols, procedures) to support cold chain / controlled temperature transportation and new process/product introductions to support supply continuity and process improvement requirements
- Providing technical input into all project phases i.e. from design through to the commissioning and qualification execution phases of the project.
- Review and approval of documents prepared by the validation team, other departments and contractor organisations (e.g. commissioning test plans, impact assessments, change controls)
- Responsible for Commissioning and Qualification documentation generation, review and approval, where appropriate including: Validation Project Plans, FMEAs/Risk Assessments, Functional Design Specification, Factory Acceptance testing, Site Acceptance Testing, IQ, OQ and PQ protocols and reports, Investigations, Commissioning Test Plans, and User Requirement Specifications as applicable.
- Resolving and assisting in the closure of deviations initiated during qualification execution.
- Implementation and co-ordination of the change control process, review change controls for validation impact, promotes timely approval of all supporting documentation.
- Generation of SOP?s / other documentation as applicable.
- Participate in the design of systems and equipment to ensure that they comply with GMP requirements.
- Co-ordinate qualification activities with contractors and vendors as required.
- Attend external training courses as required to fulfil the role of Validation Engineer.
- Assist in the development of training material for qualification activities.
- Domestic and international travel may be required (15%).
Experience with Aseptic/Sterile Manufacturing and /or Qualification experience in a project environment within the pharmaceutical or biopharmaceutical industries and/or cold chain qualifications is preferred
- Experience dealing with contract manufacturing organizations is preferred.
Author and/or review and approve validation documents related to cold chain qualifications, Drug Product process validation, equipment, and packaging and labeling qualifications for per defined policies and procedures 50%
Define strategies for external validation efforts, including development of master plans/ project plans etc. Manage and coordinate the development and execution of validation protocols, data analysis, and development of final reports. Schedule and lead meetings with CMOs, external manufacturing, regulatory affairs, quality assurance, and other personnel to gain consensus on protocol content, protocol execution, and resolution to failures to meet protocol requirements 25%
Assess quality systems including deviations, CAPAs, change controls, investigations etc. for validation impact 15%
Support authoring and review of CMC sections of filings related to external validation activities and response to questions from agencies as needed. 5%
Support continuous improvement activities related to validation, quality, and compliance. 5%
Person Spec :
Relevant 3rd Level Qualification, B.Sc. or M.Sc. in chemical/biochemical engineering or related field with validation experience in the biotech/pharma industry is required.
- Minimum of 4-5 years direct experience in a validation role in either the Medical Device or Pharmaceutical/biopharmaceutical industry preferred.
- Strong knowledge of CSV/GAMP, 21CFR Part 11, Annex 11, Project Life Cycle and quality systems, cGMPs, GDPs and FDA/EMEA guidelines and proven ability to apply guidelines to all aspects of qualification activities.
- Must be comfortable and flexible with ambiguity in a ?start up? environment, able to prioritize and multitask in a environment with changing priorities
- Firm sense of accountability, ownership for end-to-end project lifecycle and sound knowledge of project management.
- Good knowledge of statistical techniques in the use of problem solving / data analysis.
- Solid verbal and written communication and presenting skills with the ability to interact with technical and non-technical groups.
- Adaptable and flexible
- Ability to demonstrate standards of leadership - managing complexity/ Innovations / Customer Focus Flexible Team Player Good influencing skills
- Demonstrated experience in validation protocol development, execution and reporting is required.
- Experience in managing complex validation projects in a fast paced environment is required.
- Experience of Technology Transfer, Process Scale up and process improvement projects preferable.
This position requires excellent organizational and communication skills, and knowledge and understanding of regulatory requirements and industry practices is required. The incumbent must be self-motivated, able to correctly set his/her own priorities for the multiple projects that will be simultaneously managed, and meet project deadlines and budgets. Teamwork and collaboration skills are integral to the position.
The incumbent will be involved in a wide range of complex problems, which require the regular use of ingenuity and creativity, working without appreciable direction, and exercising considerable latitude in determining assignment objectives. She/he may determine the methods and procedures used on new assignments. Completed work is reviewed from a relatively long term perspective for desired results. Problems should be solved with a sound business and compliance risk assessment approach.?????
CV to firstname.lastname@example.org 01 2302400 www.rftgroup.ie