Executive Job Description | Pharma-Cruiting Life Sciences Executive Search is seeking a Director, Technical Support (Engineering) for our Contract Manufacturing client in North Carolina.
Summary
The incumbent will be responsible for providing leadership and direction in validation, utility operations, process transfers, process improvements, facility improvements and facility maintenance to ensure regulatory compliance, profitability, product quality, strategic investments, and equipment reliability.
Manage, implement and oversee Environmental programs. Manage, plan, organize, staff, control and direction of Engineering, Validation, Utilities and Maintenance groups, programs and projects. Responsible for the operation of all site utility, environmental and purified water systems and their compliance with all local, state and federal regulations. Ensures that decisions and plans are made and coordinated in accordance with legal requirements.
The Director, Technical Support will operate within the organizational structure to provide direction and management direction to Engineering, Validation, Utilities, Environmental and Maintenance activities. The person in this role will interact with the other directors, site director & VP, and VP of quality assurance. Additionally, customer interaction is required related to business proposals / opportunities, audits (quality and SHE) and regulatory (FDA, OSHA, EPA, etc.) authorities.
Director will be knowledgeable and accountable for adherence to corporate policies and work processes. Lead complex business initiatives or projects to improve operating profitability and or regulatory compliance.
Responsibilities ( 9 direct reports)
1. Business and compliance system design and execution to enhance customer focus (both internal and external) and profitability.
2. Visionary leadership of people to implement change, understand consequences and obtain commitment.
3. Coordination of complex projects requiring knowledge of the entire organization and the external environment.
4. Represent the Company in meetings with customers, making presentations and preparing business proposals.
5. Direct and manage the technical aspects (process, equipment, computer, cleaning, validation programs, process maintenance, process and project engineering functions, and facility maintenance) supporting the business strategy.
6. To set policy, provide leadership and direction in engineering, validation, environmental, utilities and systems in compliance with SOP’s, GAP’s, cGMP’s and other site procedures. Ensure that all regulatory and code requirements are met (i.e., Environmental Protection Agency (EPA), National Fire Protection Association (NFPA), National Electrical Code (NEC), Occupational Safety and Health Agency (OSHA), DEA, etc.)
7. Manage the validation group for the site and assure compliance with regulatory requirements, internal procedures and customers. Provide management to support audits, customer and capital projects, process, cleaning and equipment validation, and requalification program in support of the business objectives.
8. Manage the utility and environmental operational groups for the site and ensure they operate within the regulatory permits for both air and water emissions and provide the regulatory reporting for the systems. Provide staffing and support to operate the plant 24/7/365. Operate “clean utility” systems in a cGMP compliant state. Provide technical staff to explain and defend the cGMP compliance of purified water, water for injection and purified steam systems.
9. Direct and manage central maintenance group to assure high systems availability at the appropriate cost. Maintenance includes the calibration program for instruments, program for the certification of HEPA filters, and the maintenance of the piping & electrical systems. Maintain a cGMP compliant maintenance management system to schedule and document all maintenance work. Maintain an adequate level of spare parts. Ensure adequate resources to repair and maintain the site. Implement the corporate approach to asset management and utilization.
10. Direct the engineering and automation groups on the site. Ensure that projects are developed to support the company objectives and that they are implemented in compliance with all local, state and federal codes as well being compliant with cGMP practices. Provide engineering resources to implement capital projects as well as provide technical support to resolve production and maintenance problems.
11. Interact directly with federal, state and local legislative and regulatory agencies, public officials, and business leaders on environment, risk management and safety issues that have impact on company operations and impact to the community.
12. Develop capital and expense budgets. Monitor and control on a continual basis the expenditures for each budget. Recommend capital and expense items for landlord capital and expense budgets.
13. Ensure capital projects are performed within budget and timeline and meet intended scope.
14. Ensure capital expenses are at the appropriate level for the given scope.
15. Determine areas for potential improvement and cost effectiveness in business operations related to pollution prevention and waste management and direct the implementation of programs that improve efficiency and cost effectiveness of environmental/production operations.
16. Manage and direct corporate resources to ensure that both customer and internal corporate audits that are evaluating our level of compliance with respect to Safety, Health and Environmental matters are adequate and all findings are addressed appropriately.
17. Develop and coordinate “Service Level Agreements” between the other business groups on the site and manage the services that they are receiving.
18. Develop strategies and plans for providing overall direction to assigned engineering programs and systems in compliance with SOP’s, GAP’s, cGMP’s and other.
Required experience:
Diversified knowledge of utility & environmental operations and engineering, validation and maintenance functions and responsibilities.
Knowledge of regulations (international, federal and local) and ability to commercially satisfy these requirements to sustain the business.
Develop conceptual project concepts and execution strategies with very limited information in support of customer proposals.
Knowledge and educational level
BS or higher in Chemical Engineering or related science and Masters in Business Administration with at least 10 years experience in pharmaceuticals/fine chemicals manufacturing, with at least 5 years management experience.
Required level of experience
Regulatory requirements (FDA, OSHA, EPA) – 10 years
Validation – 3 years
Engineering – 5 years
Project Management – 3 years
Facility Maintenance – 3 years
Financial Management – 5 years
To apply: Please email ruth@pharmacruiting.com
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