RESPONSIBILITIES:
• Direct all functional accountabilities for Phoenix Technical Support in accordance with organization’s policies and procedures.
• Work closely with Site and Corporate Management (including Corporate Engineering, EHS, Pharmaceutical Technology, etc) in developing and implementing strategic plans and initiatives. Establish department goals that support site goals. Ensure employees have the resources needed to meet or exceed their goals. Provide site master planning in accordance with strategic objectives while ensuring capacity availability and expansion capabilities.
• Ensure Technical Support work areas that are compliant, efficient, effective and safe.
• Ensure all department staff receive training in cGMP’s SOP’s, Company Policies and safety, and that employees meet defined qualification requirements for
the position to which they are assigned.
• Approve departmental budgets and site long range capital planning and budgets. Ensure Cost Center Owners have appropriate information and tools needed to develop and to be held accountable to their budgets. Responsible for capital project conceptualization, planning, design, execution, and implementation.
• Select and foster a well trained, motivated and informed staff. Ensure adequate trained personnel are available to perform all Technical Support activities.
Mentor Supervisors, Managers, and Directors. Conduct department meetings. Work closely with Human Resources on Policy changes, interpretation and execution; Hiring of new employees, Employee disciplinary action, Performance Appraisals and Personnel Development. Plan and identify the department resources required which includes the selection of competent contractors through the bidding and interview process and or the hiring of new associates as required.
• Review and approve controlled documents in accordance with cGMP’s and good documentation practices.
• Participate in audits conducted by regulatory agency representatives and partners/clients.
• Approve acquisition of new equipment, and facility layout, design, and construction.
• Ensure existing equipment and facilities are maintained in a compliant and efficient manner.
• Ensure facility validation programs are maintained in a state of compliance with respect to corporate and regulatory standards. This will include revalidation
of critical equipment, utilities, facilities, GMP computer systems and processes.
• Provide Corporate Pharmaceutical Technology support during the improvement and transfer of processes and products to and from the site.
• Ensure metrology services are provided to Plant and Laboratory Operations in a compliant and efficient manner.
• Ensure studies or experiments are conducted to identify, resolve and or correct manufacturing problems or process improvements, producing reports to
substantiate findings. Involve Corporate Pharmaceutical Technology as appropriate.

Qualifications
PREREQUISITES:
• Requires a Bachelors degree preferably in Science, Engineering, or IT from an accredited college or university.
• Prefer an advanced degree.
• Requires a minimum of 12 years manufacturing, validation, technical support, and/or IT experience in a regulated industry.
• Prefer at least 7 years in the pharmaceutical industry and 7 years of progressive management experience.
• An equivalent combination of education, experience and training may substitute.
• Ensure technical support is provided to Manufacturing and Laboratory groups to ensure that all new equipment is validated, that the equipment is
maintained in a current state of validation, and resolution of problems concerning Validation compliance, equipment, cleaning and process issues. Involve Corporate
Pharmaceutical Technology as appropriate.
• Review, evaluate, sign-off or delegate the responsibility for the following documentation: Standard Operating Procedures; Capital Appropriation Requests;
Change control requests (CCR’s); Temporary Change control requests (TCCR’s); Purchase requisitions; Work Orders; Validation Protocols; Budgets for department; etc.
• Ensure collaboration with global process and technology, senior site management and IT Site Lead to develop and support strategies for business process
improvements though global information systems automation.
• Ensure coordination with global Process and Technology team and IT Site Lead to maintain supporting technologies that are compliant, efficient, effective and
reliable.
• Ensure collaborate with global Process and Technology team and IT Site Lead on planning and change management related to introduction of new capabilities
and/or planned system changes which are consistent with global and site objectives.
• Perform other duties as assigned.