5 days old

Head of Technical Functions (Engineering/Facilities, MSAT and OT)

Lonza
Walkersville, Maryland 21793
  • Job Type
    Employee
  • Job Status
    Full Time

Responsible for leading the group that provides engineering and facilities support of operations. Responsible for the overall management of engineering, capital, and operational excellence projects. The role is responsible for design, implementation, and ongoing management of best-in-class project management processes. The role will be directly responsible for overseeing the Lonza CAPEX management system for LBS.

In addition, This position has primary responsibility for the site Manufacturing, Science and Technology (MSAT) and Operational Technology (OT) functions.


Job Description:

LEADERSHIP & PEOPLE:

  • Leadership role in promoting operating requirements, practices, and documents within a cGMP compliant facility. 
  • Responsible for providing employee guidance; development and coaching to ensure the teams are aligned to the site strategy and are supporting the site to deliver on our current contracts and business pursuits.
  • Participate in site strategy decisions as a part of the site leadership team.
  • Create a high-performance team that emphasizes strengths-based execution, accountability, open communication, people development and continuous improvement.

 

ENGINEERING:

  • Responsible for aligning the Facilities and Engineering group with the company objectives and initiatives.
  • Approves plans, budgets, and facility modifications including estimates on equipment, labor, and other related costs.
  • Manages facilities and engineering staff and activities such as remodeling, construction, security, communications, contractual agreements, and writes system and equipment specifications, as well as leading lease negotiations, long-term facilities and space plans.
  • Responsible for overseeing the design, planning, construction, and maintenance of equipment, systems, and buildings, as well as building grounds keeping and custodial services.
  • Responsible for overseeing capital improvement projects, reviews and approves design plans, specifications, cost estimates, and schedules.
  • Responsible for the management and tracking of outside projects and facility operations.
  • Oversees the coordination of building space allocation, lay-out, and facility expansion, as well as the coordination of facility moves.
  • Responsible for developing criteria and performance specifications for facilities and equipment required to meet compliant GMP operating requirements, building and safety codes, and all other regulatory requirements.

 

MSAT:

  • Responsible for providing engineering solutions to meet production and business needs.
  • Plays a key role in driving process design, optimization and executing improvement initiatives.
  • Responsible for the overall process engineering and technical transfers.
  • Engage with program managers and directly with our customers to ensure projects are planned and executed appropriately in order to deliver to, and meet the needs of our customers and the business.

 

OPERATIONS TECHNOLOGY (OT):

  • Meets with System Owners to perform Data Integrity Assessments. This includes reviewing validation documents, SOPs, Audit Trail Data, system and event logs, and user accounts.
  • Responsible for various support functions for computer systems, databases, and software applications that are utilized with QC, QA, and Operations.
  • Handles routine system application administration (i.e. set up new users. roles, groups, data set up, software configuration, etc.) Administers appropriate change control, security, and backup/ recovery procedures to maintain validated and compliant status of system.
  • Provides hardware, software, and network trouble shooting support for specific applications by interfacing with end users, IT, and application vendors.
  • Supports the implementation of new computerized systems, changes, and GMP controls.

 

Quality Responsibility

  • Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates.

 

Safety Responsibility

  • Is knowledgeable and complies with all pertinent safety policies, rules and regulations.
  • Ensure that all team members comply with safety rules and regulations.

 

Requirements

Minimum Required Qualifications, Skills and Education:

  • Bachelor of Science degree in Engineering discipline
    • Preferred: Masters or PhD in Engineering discipline
  • Minimally 15+ years of biotech, pharmaceutical or medical device industry experience in process development, process scale up/manufacturing and process validation.
  • Experience with large scale manufacturing support for media manufacturing and/or analytical reagent (e.g. endotoxin detection assay) manufacture.
  • In depth knowledge of large scale biologic, pharmaceutical or medical device manufacturing, cGMP and US/EU regulations and intermediate knowledge of statistical data analysis.  
  • Knowledge should include, scale up and mass transfer, media/buffer tank operation, liquid/solid formulation & compounding, virus/sterile filtration, aseptic processing technologies and include small scale (laboratory) experience.
  • Must have a thorough knowledge of building design process, mechanical/electrical systems, construction methods and materials, building codes/standards, and environmental and safety regulations, including, but not limited to the National Electrical Code, ASHRAE, NFPA, and OSHA, and including regulatory requirements, including cGMP and 21 CFR Part 11.
  • Must have knowledge of cGMP facility design, clean room technology, and Building Management Systems.
  • Must have strong organizational skills and be able to manage and prioritize multiple projects or assignments at one time, including the ability to follow assignments through to completion and meet deadlines.
  • Knowledge of computer software/hardware, operating systems, databases, and laboratory applications.
  • Able to identify and respond to complex problems, interpret complex data and draw valid conclusions.
  • Able to write complex procedures and reports.
  • Able to communicate status, needs, forecasts, risks and timelines effectively to management.
  • Able to explain technical concepts in a manner easily understood by non-SMEs.
  • Proficient using spreadsheets, databases, project management and word processing software and must be able to read, understand, and use blueprints.

 

Categories

Posted: 2019-09-10 Expires: 2019-10-09

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Head of Technical Functions (Engineering/Facilities, MSAT and OT)

Lonza
Walkersville, Maryland 21793

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