Process Execution Team Engineer - MedImmune - 10587

Organization
MedImmune
Job Location
Philadelphia , PA
Philadelphia, PA 19019
Job Description

Job Description:

Engineer / Senior Engineer / Principal Engineer:

Responsible for ensuring one technical process exists within the Process Execution Team (Manufacturing Department)/Facility. This includes equipment, materials and procedures; overall life cycle management. Leads projects and improvement initiatives as the technical expert. Responsible for maintaining a strong relationship with the PET. Serves as the single point of contact for all technical issues.

 

  • 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
  • Leads or supports the following process improvement efforts: changeover reduction, yield improvements, OEE improvements, waste reduction, and parts management
  • Ensures success criteria for technology transfer and validation is clear and the process is capable and sustainable for the merge into the PET/Facility process
  • Deliver or support PET's and/or Facility improvement initiatives that define equipment data, equipment capabilities, utilization, efficiencies, obsolescence, and asset management
  • Initiate deviations and performs/facilitates the technical investigations and assessment of impacts
  • Authors and review documents including Standard Operating Procedures, Master Batch Records, Material Specs, Rework procedures and other forms
  • Ensuring as built drawings and documentation is completed; including SAP master data updates (equipment, asset, etc)
  • Author and review validation and change control documents such as master plans, protocols, summary reports and change requests
  • Provides input and develops user requirements for new asset procurement
  • Ensuring 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
  • Delivery or development of project justification and engineering proposals including PEP, budget and spend management
  • Implement technical training requirements for Operations/Engineering/Maintenance for new and existing processes/equipment
  • Works collaboratively within PET and Engineering Community (local, regional, global)
  • Supports technical trouble shooting (ie above line technical support)
  • Process Owner/SME for regulatory inspections and audits
  • Provides input to, and actively participates, in the annual product and periodic validation review process
  • Maintain external technical relationships and collaborates with equipment and material suppliers
  • Develops and leverages contracting OSP strategies to deliver valued improvements
  • As the Change Leader, ensure that equipment is maintained in a validated state; including management and delivery of applicable OCM Change Control activities (i.e. MBRs, SOPs, etc.)
  • Participates in the SEFM Weekend on Call Program.
  • As business needs dictate, requirement to work second, third and weekend shifts to ensure full coverage/oversight for the team and to engage all SEFM personnel in product launches, continuous improvement, system ownership, site shutdown activities, and self-directed mechanic and technician work team activities.
Requirements

Position Requirement

  • BS in Engineering, pharmacy or related science
  • 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).

 

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).

 

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.

 

Education:

 

Engineer / Senior Engineer:

  • Minimum Bachelor's degree in Engineering field  or related scientific discipline
  • Professional certification – preferred.

 

Principal Engineer:

  • Master’s degree in engineering  or related scientific discipline
  • Black Belt Six Sigma certification and experience working in a lean environment - preferred.

 

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation.

About Our Organization

MedImmune does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on MedImmune's approved agency list. Unsolicited resumes or candidate information submitted to MedImmune by search/recruiting agencies not already on MedImmune's approved agency list shall become the property of MedImmune and if the candidate is subsequently hired by MedImmune, MedImmune shall not owe any fee to the submitting agency.

MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

Information submitted will be used by MedImmune and its contracted partners for activities related to your prospective employment. MedImmune respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy.

MedImmune, LLC is an Equal Opportunity/Affirmative Action Employer

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