Requisition ID 14683BR
Title Validation Area Specialist II-PrEng& Inv
Job Category Validation
Job Description Position Purpose:
Primary responsibility is to lead validation project management for capital projects. Scope of projects includes computers, facility, utility, equipment and processes associated with the production of insulin products. Serves as primary interface between project managers and quality assurance.
Project management includes the following activities:
• Providing technical input regarding requirements and design
• Evaluate, select, and coordinate contract resources
• Prepare validation plans to ensure validation activities are in accordance with applicable FDA, EU and NN requirements
• Actively manage portfolio of projects and budgets to ensure projects are completed on time and on budget
Actively participates in regulatory and internal audits and is able to defend validation concepts/approaches with auditors in a professional manner. Leads validation failure investigations and non-conformities utilizing root cause analysis techniques. Lead change control activities for capital projects. Lead commissioning efforts for systems/processes and identify process improvements before systems/processes are placed under change control during validation.
Education: BS/MS in Engineering, Computer Science, or applicable technical degree or related field or equivalent combination of education and experience.
Experience: Minimum 8 years validation experience in pharmaceutical environment. Minimum of 3 years of demonstrated project management experience. Knowledge of all core validation areas with at least 2 areas of deep understanding and experience (sterilization, packaging, assembly, utilities, cleaning, process or computer validation).
Technical/Process/Functional Knowledge: Knowledgeable in the following areas: Expert in validation concepts with expert competence in one or more core areas (sterilization, packaging, assembly, cleaning, utilities, process or computer validation). Expert in root cause analysis techniques and cGMP documentation practices. Expert understanding of change control processes. Hands on experience preparing protocols, executing data analysis, and report writing. Expert understanding of validation/system development life cycle approach. Basic computer skills including experience in the use of Microsoft word, Excel, etc. Excellent technical writing and oral communication skills. Expert knowledge of statistical methods. Expert in cGMP regulations. Expert knowledge in being a project team leader. Excellent negotiation and conflict resolutions skills. Excellent presentation and facilitation skills. Ability to interact with all levels of the organization. Able to operate with a high level of autonomy and authority. Capable of establishing and communicating high standards and expectations for performance and holding team members accountable for results. Strong analytical/reasoning, organizational and multi-tasking skills. Puts in time and effort needed to exceed goals under demanding circumstances. Regularly follows up on goals without letting time pass in order to ensure progress and goal attainment.
Physical / Other Requirements:
Ability to lift up to 40 lbs. with assistance.
Ability to work in confined spaces and near operating equipment.
Ability to be clean room certified.
Ability to accommodate extensive international travel. Ability to work in loud noise environments.
Ability to work hours necessary to support project, 24/7 production and /or maintenance activities.
Department Investments and Project Engineering
Position Location US - Clayton, NC
City Clayton
State/Provinces US - NC
Degree Required Bachelor's Degree Required
Percent Travel 10 - 20%
Title Validation Area Specialist II-PrEng& Inv
Job Category Validation
Job Description Position Purpose:
Primary responsibility is to lead validation project management for capital projects. Scope of projects includes computers, facility, utility, equipment and processes associated with the production of insulin products. Serves as primary interface between project managers and quality assurance.
Project management includes the following activities:
• Providing technical input regarding requirements and design
• Evaluate, select, and coordinate contract resources
• Prepare validation plans to ensure validation activities are in accordance with applicable FDA, EU and NN requirements
• Actively manage portfolio of projects and budgets to ensure projects are completed on time and on budget
Actively participates in regulatory and internal audits and is able to defend validation concepts/approaches with auditors in a professional manner. Leads validation failure investigations and non-conformities utilizing root cause analysis techniques. Lead change control activities for capital projects. Lead commissioning efforts for systems/processes and identify process improvements before systems/processes are placed under change control during validation.
Education: BS/MS in Engineering, Computer Science, or applicable technical degree or related field or equivalent combination of education and experience.
Experience: Minimum 8 years validation experience in pharmaceutical environment. Minimum of 3 years of demonstrated project management experience. Knowledge of all core validation areas with at least 2 areas of deep understanding and experience (sterilization, packaging, assembly, utilities, cleaning, process or computer validation).
Technical/Process/Functional Knowledge: Knowledgeable in the following areas: Expert in validation concepts with expert competence in one or more core areas (sterilization, packaging, assembly, cleaning, utilities, process or computer validation). Expert in root cause analysis techniques and cGMP documentation practices. Expert understanding of change control processes. Hands on experience preparing protocols, executing data analysis, and report writing. Expert understanding of validation/system development life cycle approach. Basic computer skills including experience in the use of Microsoft word, Excel, etc. Excellent technical writing and oral communication skills. Expert knowledge of statistical methods. Expert in cGMP regulations. Expert knowledge in being a project team leader. Excellent negotiation and conflict resolutions skills. Excellent presentation and facilitation skills. Ability to interact with all levels of the organization. Able to operate with a high level of autonomy and authority. Capable of establishing and communicating high standards and expectations for performance and holding team members accountable for results. Strong analytical/reasoning, organizational and multi-tasking skills. Puts in time and effort needed to exceed goals under demanding circumstances. Regularly follows up on goals without letting time pass in order to ensure progress and goal attainment.
Physical / Other Requirements:
Ability to lift up to 40 lbs. with assistance.
Ability to work in confined spaces and near operating equipment.
Ability to be clean room certified.
Ability to accommodate extensive international travel. Ability to work in loud noise environments.
Ability to work hours necessary to support project, 24/7 production and /or maintenance activities.
Department Investments and Project Engineering
Position Location US - Clayton, NC
City Clayton
State/Provinces US - NC
Degree Required Bachelor's Degree Required
Percent Travel 10 - 20%