Job Title : Technical Operations Lead
Department : DS Vaccines Op Unit
Position Reports to : Operating Unit Lead
Applications will close 17 July 2018.
Job Purpose :
Coordinate the delivery of a robust process and reliable equipment in support of a Right First Time Operating Unit. Lead a team of Subject Matter Experts and be the focal point for communications with the Core Technical Service and Core Engineering groups.
Create and drive innovative strategies to ensure the future growth of the Vaccines business. This candidate will be a member of the Operating Unit Leadership Team and work in support of the Operating Unit Goals and Objectives.
Job Responsibilities : Engineering
Implement equipment CAPA’s and performance improvements
Manage the execution of routine equipment maintenance & calibrations.
Execute equipment validation & revalidation protocols.
Provide equipment technical support and troubleshooting.
Provide routine Automation support, troubleshooting and maintenance.
Champion and drive the implementation of GRP tools and techniques within the Operation Unit. (for eg. Operator Care, PdM, PMO, Work Management)
Drive the use of Informatics to provide business efficiency.
Identify equipment improvement projects for Core Engineering Unit.
Work with the Hoshin management process to prioritise projects / support demands from the Core Units.
Support the consistent application of maintenance systems, standards and best practice.
Champion and Support Energy saving programs / projects within the Operating Unit.
Identify and manage equipment training requirements.
Priorities engineering projects based upon the achievement of future plan of record through both robustness and capacity.
Champion early remediation of equipment issues to prompt trending eg Consistent attendance at morning ops meeting promoting awareness of recurring issues.
Manage assigned chapters of APQR
Manage & Write process impact assessments to support investigation closure
Manage teams Implementation of process CAPA’s and performance improvements
Conduct Investigation Trending
Routine process technical support and troubleshooting
Active participation of Network process teams driving agenda items in support of GC operational challenges.
Build relationships with technical colleague across the Network that support collaborative approach to issue resolution.
Manage assigned Continuous Process Verification actions and ensure focus and action are assigned appropriately.
Ensure that across the conjugate business appropriate and consistent decisions are made that can be defended within an external audit.
Ensure that Vaccines robustness efforts are prioritised in support of manufacturing, disposition and compliance requirements.
Deliver Yield Standards in support of Budget cycle each year
Build relationships and maintain effective collaboration with all internal stakeholders as well as the external network.
Champion and lead OpU Manufacturing Excellance program through engagement and regular GEMBA.
Provide OpU leadership to Drive and ensure compliance within the OpU, Deviation, Change Control and Data Integrity management
Lead a highly skilled team. Provide an environment that is both challenging and allows them to develop and grow.
Staying current with external regulatory and compliance environments (EU / US / ROW) through literature review and conference attendance.
Ensuring teams attendance and full engagement of continuous audit readiness forums.
Actively working on OpU strategy to facilitate future growth and new products.
Participate in cross-functional project teams as applicable
Provide input and work with the OpU leadership team to deliver the OpU objectives.
KPIs / Deliverables for the Role :
OEE / Equipment availability performance.
Process reliability performance
Technical investigation and change controls closed in support of OpU metrics
Manage the maintenance and repair budget for the Operating Unit.
Ensure 5S standard is maintained in all Technical Operations areas.
Yield performance against standards
Compliance performance for external Audits
Repeat Deviation metric.
Key Challenges for the Role :
Personnel management and leadership of Technical Operations team
Relationship management of Core Tech Services, Core Engineering Team, Quality & QC as well as external site stakeholders (Andover, Sanford, Puurs)
Prioritization of multiple resource demands in support of Op Unit objectives
Cross training and development of skill sets of team so that they become the experts on their products
Working with Core Units to ensure that the technical expertise and skills of the Technical Support team are maintained and continually developed, including Maintenance Technicians.
Responsibility for the Maintenance Technician teams.
Being a technical leader that can drive decision making whilst creating a collaborative environment across the OpU, GC and the Vaccines Network
Represent the Operating Unit in Audits
Prepare and Present to Network Stakeholders and other high profile visitors
Min qualification - Degree level or equivalent
Further qualification - Higher Scientific or Engineering qualification.
12+ years of relevant experience
Industry Preferably Biopharmaceutical / Pharmaceutical
Role Supervision / management preference for regulated compliance environment (5 years)
Project Business planning or project management experience
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.