Facilities Engineer / Senior Engineer / Principal Engineer - (Philadelphia, PA) - Philadelphia, PA | Biospace
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Facilities Engineer / Senior Engineer / Principal Engineer - (Philadelphia, PA)

MedImmune, LLC

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Location:
Philadelphia, PA
Posted Date:
8/20/2017
Position Type:
Full time
Job Code:
R-011362
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:

Job Description

Location:
Philadelphia, Pennsylvania, United States
Job reference: R-011362
Posted date: Jul. 25, 2017

At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Facilities Engineer / Senior Engineer / Principal Engineer in Philadelphia, PA you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.

Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.

Main Duties and Responsibilities

Description

Facilities Engineer / Senior Engineer / Principal Engineer will be responsible for improving the reliability of equipment, processes, utilities, facilities and safety/security systems by incorporating good engineering practices and the principles of Reliability Centered Maintenance.  Facilities Engineer / Senior Engineer / Principal Engineer will be assigned projects and will need to manage multiple assignments/projects towards a successful outcome.  Applies practical engineering theories and practices in managing the assigned work.  Identifies cost reduction opportunities and ensures projects are completed on schedule and within budget.  Defines, develops, administers and refines the maintenance program for all assets.

Major Responsibilities

  • You will ensures there are technical processes with centerlines, standard work, critical process parameters identified, material specs and operating procedures are clear and delivers a quality product
  • You will lead or support the following process improvement efforts: changeover reduction, yield improvements, OEE improvements, waste reduction, and parts management
  • You will ensure success criteria for technology transfer and validation is clear and the process is capable and sustainable for the merge into the Facility process
  • You will deliver or support Facility improvement initiatives that define equipment data, equipment capabilities, utilization, efficiencies, obsolescence, and asset management
  • You will performs/facilitate the technical investigations and assessment of impacts
  • You will author and review documents including Standard Operating Procedures, Material Specs, Rework procedures and other forms
  • You will ensure as built drawings and documentation are completed; including SAP master data updates (equipment, asset, etc) 
  • You will author and review validation and change control documents such as master plans, protocols, summary reports and change requests
  • You will provide input and develop user requirements for new asset procurement
  • You will ensure projects are designed and installed in compliance with all company standards, SOP policies and guidelines, including but not limited to the PPM.  All design and construction complies with all Regulatory Agencies, Safety, Health and Environmental codes and regulations
  • You will manage delivery and development of project justification and engineering proposals including PEP, budget and spend management
  • You will implement technical training requirements for Operations/Engineering/Maintenance for new and existing processes/equipment
  • You will work collaboratively within PET and Engineering Community (local, regional, global)
  • You will support technical trouble shooting (i.e., above line technical support)
  • You will be the Process Owner/SME for regulatory inspections and audits
  • You will provide input to, and actively participate in, the annual product and periodic validation review process
  • You will develop and leverage contracting OSP strategies to deliver valued improvements
  • As the Change Leader, you will ensure that equipment is maintained in a validated state; including management and delivery of applicable OCM Change Control activities (i.e., MBRs, SOPs, etc.)

Requirements

Essential Requirements

Minimum Requirements

Facilities Engineer

  • Minimum 2 years experience in GMP or regulated production environment.
  • BS in Engineering, pharmacy or related science preferred.
  • Training or experience in the applicable following technologies: aseptic/controlled environment, unit operations, formulation, packaging, validation, technology transfer, change control, applied statistics ,mechanics, hydraulics, pneumatics, vacuum technology, electronics, programmable logic controllers, refrigeration, freeze drying, test equipment for electrical and mechanical trouble shooting, HVAC
  • Proficiency in at least one of the following disciplines: equipment, process/materials, maintenance, project delivery
  • Equipment/System/Project/Process Life Cycle Management and Execution including project management (schedule, sanction ,spend, and stakeholders)
  • Solid organization, problem solving and decision-making
  • Solid team work and communication skills (oral and written)
  • Working knowledge of Microsoft Office Suite (Word, Excel, Project)

Facilities Senior Engineer

  • Minimum 5 years experience in GMP or regulated production environment working with the applicable following technologies:  aseptic/controlled environment, unit operations, formulation, packaging, validation, technology transfer, change control, applied statistics, mechanics, hydraulics, pneumatics, vacuum technology, electronics, programmable logic controllers, refrigeration, freeze drying, test equipment for electrical and mechanical trouble shooting, HVAC
  • 3+ years of leadership and project management skills
  • Demonstrated ability to simultaneously manage multiple projects
  • Proficiency in all of the following disciplines equipment, process/materials, maintenance, project delivery
  • Expertise in at least one of the following disciplines equipment, process/materials, maintenance, project delivery
  • Proven ability to work in a global environment to deliver standardization across the business
  • Working knowledge of Microsoft Office Suite (Word, Excel, Project)

Facilities Principal Engineer

  • Minimum 8 years experience in GMP or regulated production environment or equivalent post-graduate academic experience with 5 years work experience
  • Expertise in two more of the following discipline equipment, process/materials, maintenance, project delivery
  • Site expert in a specific area applicable to multiple Packaging / Formulation Technologies or Facilities Management
  • 5+ years of strong leadership and project management skills
  • Advanced knowledge of cGMPs and FDA policies/procedures including experience interacting with regulatory authorities
  • Ability to work effectively as a leader and /or member of cross-functional team
  • Demonstrated ability to simultaneously manage multiple projects of high complexity
  • Assists the Engineering Leader in aspects of performance management; including team and personnel development, mentoring and coaching of other members of the SEFM team
  • Application of Microsoft Office Suite (Word, Excel, Project) for project delivery
  • Working knowledge of TDMS, SAP, OCM
  • Experience in Six Sigma/ analytical trouble shooting skills
  • Experience working in a LEAN environment

Desirable Requirements

Preferred Background

Facilities Engineer

  • Strong verbal and written communication skills; influences others to act with full understanding
  • Proven ability to work effectively in a team environment; driving team and personal accountability
  • Ability to generate and interpret technical documents
  • Experienced in managing external technical relationships
  • Strong mechanical/technical aptitude
  • Experienced in working in a LEAN manufacturing environment
  • Working knowledge of TDMS, SAP, OCM, TrakSys

Facilities Senior Engineer

  • Advanced technical degree or professional certification
  • Proven experience leading a team of technical personnel
  • Uses their insight to challenge and adapt current approaches/ways of doing things
  • Experience in Six Sigma/ analytical trouble shooting skills
  • Application of Microsoft Office Suite (Word, Excel, Project) for project delivery  
  • Working knowledge of TDMS, SAP, OCM, TrakSys

Facilities Principal Engineer

  • Mechanical/technical experience in more than one discipline
  • Management of multiple initiatives across a varied scope
  • Proven ability to develop team dynamics as well as personnel
  • Proven ability to work with all levels within the organization – locally and globally
  • Masters degree in an engineering or related scientific discipline
  • Black Belt Six Sigma certification and experience working in a lean environment
  • Advanced knowledge of TDMS, SAP, OCM, TrakSys

Direct/Indirect Reports

  • Direct Reports: 0
  • Indirect Reports: teams of up to 10 people including maintenance personnel, QA, PET/customers, and SHE delivering continuous improvement, capital projects, and deviation resolution

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

~bsp

*LI-MEDI