- Bachelor’s degree required in Mechanical or related Engineering field of study.
- 7-10 years pharmaceutical and/or Pharmaceutical/Consumer Healthcare industry experience including implementing\ optimizing preventative maintenance programs; experience with vendor negotiations on price and schedule and competitive bid practices.
- 5 years in a managerial/ leadership position.
- Prior experience in the design regulations for pharmaceutical manufacturing validation to meet FDA requirements.
- Background and knowledge and managing capital projects, meeting deadlines and budgets
- Knowledgeable in cGMP compliance, EHS standards and Engineering guidelines/standards.
- Demonstrated successes in meeting project time lines and budgets.
- Demonstrated technical understanding of the pharmaceutical industry and engineering practices.
- Demonstrated ability to generate options to resolve problems, prioritize solutions, determine appropriate course of action, gain consensus on recommendations and implement decisions.
- The ability to champion change and innovation, drive execution and results, motivate others and foster collaboration at all levels of the organization.
- The ability to delegate, train and evaluate, Coach, and mange the discipline of others.
- Sufficient technical experience required to maintain leadership over external contractors.
- The ability to drive site objectives and results; work in a fluid environment; drive culture & lead area initiatives.
- Demonstrated organizational skills and attention to detail, ability to function in an atmosphere of constant change with detailed accuracy.
- Demonstrated interpersonal and leadership skills. The ability to function within team based organization.
- The ability to communicate effectively, both verbally and in writing, to all levels within the organization as well as the skills to communicate site operations to outside groups.
- Able to interact with peers, subordinates and senior personnel in multidisciplinary environment. Ability to work in a highly complex matrix environment.
- Must lead a diverse group of professionals and non-exempt staff in a quick paced, continuously changing dynamic environment.
- Must be able to lead teams to clear hurdles or issues quickly in order to maintain schedule and morale. Must provide leadership to give project teams the confidence needed for success.
- Sense of urgency, flexibility and accountability.
- Ability to follow written procedures and document results in a neat and precise manner.
- Must be able to use computer skills in a variety of ways.
- Stay current on developments in the field of Engineering.
- Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines.
Post Graduate Business or Project Management Qualification
Six Sigma Black Belt or Process Improvement Qualification.
- Plan, manage, organize and harmonize engineering activities and capital investments in line with GSK/GMS standards. Plan and coordinate appropriately site investment on construction projects for buildings, equipment, and processes in line with cGMP, FDA, and local regulatory expectations.
- Responsible for leading the Maintenance Support Team efforts on preventive and facility maintenance ensuring proper application of procedures for procurement of spare parts and creation of SOPs for all new equipment installations for a smooth transition through validation into operation.
- Oversee plant Environmental Health and Safety programs to meet compliance to all regulatory groups, agencies and ensure a safe and productive environment.
- Support as a member of the Site Leadership Team all plant Engineering activities and site improvement initiatives and results. Ensure objectives are aligned with site goals and objectives
- Manage all Aiken site capital projects, process improvement projects and infrastructure upgrade projects.
- Direct and manage site engineering department to clearly define project objectives, map out construction and procurement strategies, identify resources necessary for project completion and develop costs and schedules to ensure flawless execution of project requirements and goals.
- Champion the developer’s agreement between GSK and internal and external contractors to completion.
- Foster relations between the three parties to build trust and streamline the process.
- Ensure compliance with legal constraints, international standards and corporate regulations (cGMP, FDA, NIH, OSHA).
- Ensure appropriate application of GSK GMS technical standards and guidelines to achieve project plans / goals.
- Preparation of investment, engineering and restructuring projects in collaboration with external contractors.
- Participate in energy conservation initiative through engineering surveys, design specifications and project execution.
- Direct and manage personnel activities such as training, performance management, hiring and evaluations, discipline and identification of development opportunities.
- Ensure appropriate SOPs/MSPs, calibration documentation and PM checklists are developed and approved as part of project deliverables.
- Contribute fully to a climate for success in project teams: foster enthusiasm and teamwork, build relationships, reward and celebrate achievement.
- This role is accountable to deliver all GSK Aiken site projects on time and within budget according to GSK Aiken standards and those of the applicable regulatory authorities.
- Lead Engineering group to assure GSK Aiken design and technical standards are implemented on projects to assure quality standards.
- Coordinate resources required to complete all activities in a timely manner to meet project time lines, including projects, time lines, people and budget.
- Manage site SMR project list and capital project list from scope development through validation to turnover. Meet with key stakeholders to determine site priorities and negotiate based on area needs and available resources.
- Direct impact on timing and budget for GSK Aiken projects and consequently on future strategic products and sales.
- Direct impact on standardization of delivered equipment by designing and maintaining specifications.
- Influence IQ and OQ protocols and execution.
You may apply for this position online by selecting the Apply now button.
GlaxoSmithKline is an equal opportunity employer, M/F/D/V - and we are proudly committed to diversity in our workforce.
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GlaxoSmithKline plc (GSK) is a global healthcare group, which is engaged in the creation and discovery, development, manufacture and...