POSITION SUMMARY

•Provide engineering and technical support (for design, installation, startup/commissioning, testing, validation /qualification, operation and maintenance) of GMP utilities and systems within a biopharmaceutical manufacturing environment in Andover, Massachusetts.  The GMP utilities in scope include Purified Water, WFI, Clean Steam, Process Gases, (Compressed Air, CO2, N2, and O2) systems.

POSITION RESPONSIBILITIES

Job Duties and Responsibilities

•Provide engineering design solutions for reliable supply of GMP Utilities (Purified Water, WFI, Clean Steam, Process Gases) to end users, while ensuring quality and compliance specifications are met / exceeded.

•Provide engineering support to develop scope of work, project execution plans, and associated engineering studies for equipment / component installation, modification, replacement, in accordance with site specifications. Revise drawings, P&IDs, SOPs and develop test plans leveraging site project management and change control procedures.

•Support the development of design, startup and test documents including User Requirement Specification (URS), Functional Requirement Specification (FRS), commissioning and qualification test plans, as applicable.

•Provide technical trouble shooting support using Root Cause Failure Analysis (RCFA), Method 1 or Pfizer Human Performance investigations with good engineering practices and problem solving techniques.

•Support proactive reliability assessments including data collection, Failure Modes and Effects Analysis (FMEA), Fault Tree Analysis (FTA), HAZOP analysis and process improvement initiatives. Leverage data to optimize PM plans and materials of construction for robust asset performance.

•Interface with External Clients, Auditors, Regulatory Agencies and Internal Partners and communicate effectively with all coworkers, clients, vendors, contractors, and visitors.

•Support Quality system elements including but not limited to investigations, audits, change controls, revalidations, inspections etc. Participate in Environmental Review Committee (ERC) meetings and perform investigations, as necessary.

•Support Facility / Utility Shutdown efforts to complete planned preventive / corrective maintenance and capital projects.

•Ensure that all work is performed in accordance with SOPs, cGMPs, safety procedures, quality standards, OSHA standards, other regulatory agency standards, and good maintenance practices.

•Promote safety within the workplace by following site safety procedures and perform proactive safety assessments, foster a safe work culture.  Incorporate safety, cGMP, and regulatory compliance into all job functions and recommendations.

•Provide off-shift and on call support when necessary

•Actively participate in site & corporate initiatives such as Communities of Practice, Limited Duration Teams.

Qualifications

•Candidate should have a BS in Chemical or Mechanical Engineering or relevant discipline (ie. Biomechanical Engineering) + minimum of 0 - 2 years of industry experience

•Knowledge of Purified Water, WFI, Clean Steam, generation / distribution system design and operation in addition to Process Gases in a cGMP biopharmaceutical environment.

•Candidate must be able to work across functional areas such as operations, maintenance, quality and regulatory.

•Good communication skills, verbal and written, are required.

•Ability to read and generate documents such as Piping & Instrumentation Diagrams (P&IDs), User Requirement Specifications (URS), Functional Requirement Specifications (FRS) and Qualification documents.

EDUCATION AND EXPERIENCE

•Minimum Requirements: Candidate should have a BS in Chemical or Mechanical Engineering or relevant discipline (ie. Biomechanical Engineering) + minimum of 0 - 2 years of industry experience.

TECHNICAL SKILLS REQUIREMENTS

•Possess interpersonal, oral and written communication skills.

•Ability to communicate effectively with quality, engineers, and maintenance individuals.

•Ability to shift priorities according to changes in departmental/facility needs and be open to different ideas/approaches.

•Be highly motivated, show initiative, and work well independently or in a team environment.

•Demonstrated skills in using computer systems and software such as Microsoft Office Products.

•Demonstrated ability to analyze equipment failures using personal knowledge and internal and external resources.

PHYSICAL/MENTAL REQUIREMENTS

•            Uses a variety of communication tools and techniques to explain difficult issues and works to establish consensus

Role in Team Interaction

•            Participates and contributes as a team member

•              Takes responsibility for a portion of the work team’s milestones/ deliverables

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

standard work

Relocation assistance may be available based on business needs and/or eligibility.