Process Engineering Manager - Compliance and Safety
Location:
Rockville , Maryland
Posted:
December 15, 2017
Reference:
WD137788
Basic qualifications:
• 10 years in Engineering and Plant Operations. Familiarity with biopharm mechanical, electrical, instrumentation, computer and process equipment.
• Demonstrated project management expertise
• Understanding of the requirements of a Pharma/regulated environment.
• Broad knowledge of the engineering professional environment and associated disciplines /skills.
• Able to communicate effectively at 360 degrees and with various external parties.
• Accountable for upholding agreed standards of practice with TP13 preferred
• Relevant previous experience of managing diverse project teams in a dynamic manufacturing environment
• Good understanding across multiple functions
• Good understanding of business processes.
• Strong planning and program management skills
• Effective organization, communication, presentation and influencing skills

Preferred qualifications:
o Strong engineering technical skills in mechanical, chemical, and electrical / computer disciplines
o Extensive knowledge of biopharmaceutical equipment and manufacturing processes (including controls)
o Demonstrated effective management of significant capital and ownership of systems subject to audits from oversight groups and regulatory bodies.
o Demonstrated capability of leading large matrix organizations with excellent communication, influencing, and coaching abilities at all levels within the organization
o Leadership skills that enable the introduction of new ways of working and accelerated change management
o Proven capability to lead and motivate teams (line & matrix; and multi-disciplinary & cross-functional) to deliver business solutions and benefits
o Demonstrate initiative, creative, and analytical problem solving skills - ability to use and interpret data to drive decision making at both tactical and strategic level

Details:
This role will lead the engineering statutory and compliance activities for site and own the site engineering standards, specifications, and auditable compliance framework. This role will be ultimately responsible for site engineering adherence to all GSK global engineering and EHS standards and manage all activities and budgets required to keep our adherence excellent. This role will be primary interface above site to central standards teams and across sites to peer engineering compliance managers to ensure consistency in our program and initiatives. This role will also be primary interface between site engineering and EHS functions to assure proper and timely engineering execution of EHS capital projects, EHS suggestions, actions from safety incidents, PTW, and EHS compliance initiatives. The role will also own major engineering compliance initiatives arising from engineering blue chips (such as PCCE, Basis of Safety, Process Safety, Legionella, and Boilers) and major compliance events (TP13). This role will is recognized as the technical expert in process safety related to site engineering and thus own programs such as RBI and hazardous area classification. Finally, this role will own and be ultimately responsible for all engineering support systems (MERP PM, PM deviations, drawing management, turnover packages, Webtop, ACRs / Test Plans) as they pertain to compliance. Due to the role's criticality and centrality to the site's engineering performance, it will serve on the site's engineering leadership team.

• Lead the engineering statutory and compliance activities for site which includes establishing Key Performance Indicators (KPIs) and report monthly progress against targets:
o GESs, Eng. Alerts, Eng. Blue Chips, TP13
• Own the site engineering standards, specifications, auditable compliance framework, and QMS systems and adherence to all GSK global engineering and EHS standards including
• Manage all engineering activities and budgets required for above.
• Own major engineering compliance initiatives and events.
• Be recognized as the technical expert in process safety related to site engineering.
• Responsible for all engineering support systems as they pertain to compliance.
• Primary interface with central engineering, site EHS, and other site's compliance managers
• Participate and be part of site engineering leadership team
• To lead the training, standard work, and performance management to ensure that engineering activities are performed consistently in a safe and efficient manner compliant to all statutory and GSK standards

Contact information:

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