Process Project & Validation Engineer
Melbourne | careers.ipsdb.com |
Job Description:
At IPS, you will apply your knowledge, skills, and passion to make a difference in the lives of people by solving complex challenges related to pharmaceutical, biotech, and animal health research and manufacturing facilities.
Key Activities And Responsibilities
• Develops working knowledge of prime contract requirements and applies knowledge to project activities.
• Strong Process and Validation knowledge of BioPharma Life Science equipment, regulatory cGMP knowledge
• Supports the Lead Process Engineer in the development and maintenance of preconstruction, construction, and closeout execution plans. Coordinates review and approval from the Lead Process Engineer and communicates this information to the project team.
• Supports Lead Process Engineer in the development and maintenance of written project scopes of work and communication of this information to the project team.
• Supports the Lead Process Engineer in facilitating communication between project participants and produces documentation of communication between project participants. Supports the Lead Process Engineer in the development and maintenance of project schedules, including targeted and actual activities lists, durations, and sequencing logic, and communicates this information to the project team.
• Develops a working knowledge of the scope of the project budget and identifies exceptions to the project budget throughout the execution of the project.
• Participates in Safety reviews and/or Pre-planning / JSA meetings as necessary.
• Review all shop drawings and submittals and ensure that the submittals and shop drawings are in conformance with the design before submission to the design professional.
• Assist with Punch List management.
• Assist the Lead Process Engineer in completing the close-out requirements and Turnover Documents (TOPs).
• Supports the Lead Process Engineer in monitoring and reporting project costs.
• Supports the Lead Process Engineer in the development of change control documentation and related financial documentation. Vigorously protects corporate positions.
• Develops a thorough understanding of contractually required quality in design and construction and supports quality assurance for the project.
• Supports Lead Process Engineer in the coordination of safety resources to monitor site safety and correct nonconformances.
• Monitors design content and quality and coordinates design revisions for constructability and compliance with basis documents, schedule, and budget.
• Supports Lead Process Engineer in the procurement and coordination of all required project resources, including intra-divisional, interdivisional, and extra corporate.
• Supports the Lead Process Engineer in the preparation of subcontracts, purchase orders, change control documentation, and related financial documentation.
• Supports the Lead Process Engineer in the evaluation of vendor and subcontractor invoices.
• Works with Document Control to ensure that all project documents are distributed, reviewed, and stored to meet project and corporate requirements. Project documents include records of communications, design documents, bid packages addenda and bulletins thereto, and submittals, among others.
• Supports the Lead Process Engineer in ensuring compliance of project activities with legal and regulatory requirements.
• Coordinates resources to achieve project goals.
• Interacts with clients on assigned projects and promotes positive relationships.
• Other duties as assigned.
Qualifications & Requirements:
• Bachelor’s degree in Engineering, Validation, or a related discipline or an equivalent technical degree.
• 5+ years of experience in Engineering, Validation, or a related discipline within the Life Sciences industry.
• Knowledge of cGMPs as they affect process design and equipment specification.
• Strong Process and Validation knowledge of BioPharma Life Science equipment, regulatory cGMP knowledge.
About Us:
IPS, a Berkshire Hathaway Company, is a global leader in developing innovative business solutions for the biotechnology and pharmaceutical industries. Through operational expertise and industry-leading knowledge, skill, and passion, IPS provides consultancy services, architecture, engineering, project controls, construction management, and compliance services that allow clients to develop and manufacture life-impacting products.
Its newest acquisition, Linesight, specializes in cost, schedule, risk, program, and project management services in various market sectors, including data centers, life sciences, and high-tech industries. With the addition of Linesight, IPS has over 3,000 professionals in over 45 offices across 17 countries in the Americas, Europe, Asia Pacific, Southeast Asia, Australia, and the Middle East.
Specialties
Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV and Staffing Services.
All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.
IPS is proud to be an affirmative action and equal opportunity employer.
Attention Search Firms / Third-Party Recruiters: IPS is not seeking assistance or accepting unsolicited resumes from search firms for employment opportunities with IPS. Regardless of past practice, all resumes submitted by search firms to any employee at IPS via email, the Internet, or directly to hiring managers at IPS in any form without a valid written search agreement in place for a specific position will be deemed the sole property of IPS, and no fee will be paid in the event a candidate is hired by IPS as a result of the referral or through other means.
#LI-TF1
At IPS, you will apply your knowledge, skills, and passion to make a difference in the lives of people by solving complex challenges related to pharmaceutical, biotech, and animal health research and manufacturing facilities.
Key Activities And Responsibilities
• Develops working knowledge of prime contract requirements and applies knowledge to project activities.
• Strong Process and Validation knowledge of BioPharma Life Science equipment, regulatory cGMP knowledge
• Supports the Lead Process Engineer in the development and maintenance of preconstruction, construction, and closeout execution plans. Coordinates review and approval from the Lead Process Engineer and communicates this information to the project team.
• Supports Lead Process Engineer in the development and maintenance of written project scopes of work and communication of this information to the project team.
• Supports the Lead Process Engineer in facilitating communication between project participants and produces documentation of communication between project participants. Supports the Lead Process Engineer in the development and maintenance of project schedules, including targeted and actual activities lists, durations, and sequencing logic, and communicates this information to the project team.
• Develops a working knowledge of the scope of the project budget and identifies exceptions to the project budget throughout the execution of the project.
• Participates in Safety reviews and/or Pre-planning / JSA meetings as necessary.
• Review all shop drawings and submittals and ensure that the submittals and shop drawings are in conformance with the design before submission to the design professional.
• Assist with Punch List management.
• Assist the Lead Process Engineer in completing the close-out requirements and Turnover Documents (TOPs).
• Supports the Lead Process Engineer in monitoring and reporting project costs.
• Supports the Lead Process Engineer in the development of change control documentation and related financial documentation. Vigorously protects corporate positions.
• Develops a thorough understanding of contractually required quality in design and construction and supports quality assurance for the project.
• Supports Lead Process Engineer in the coordination of safety resources to monitor site safety and correct nonconformances.
• Monitors design content and quality and coordinates design revisions for constructability and compliance with basis documents, schedule, and budget.
• Supports Lead Process Engineer in the procurement and coordination of all required project resources, including intra-divisional, interdivisional, and extra corporate.
• Supports the Lead Process Engineer in the preparation of subcontracts, purchase orders, change control documentation, and related financial documentation.
• Supports the Lead Process Engineer in the evaluation of vendor and subcontractor invoices.
• Works with Document Control to ensure that all project documents are distributed, reviewed, and stored to meet project and corporate requirements. Project documents include records of communications, design documents, bid packages addenda and bulletins thereto, and submittals, among others.
• Supports the Lead Process Engineer in ensuring compliance of project activities with legal and regulatory requirements.
• Coordinates resources to achieve project goals.
• Interacts with clients on assigned projects and promotes positive relationships.
• Other duties as assigned.
Qualifications & Requirements:
• Bachelor’s degree in Engineering, Validation, or a related discipline or an equivalent technical degree.
• 5+ years of experience in Engineering, Validation, or a related discipline within the Life Sciences industry.
• Knowledge of cGMPs as they affect process design and equipment specification.
• Strong Process and Validation knowledge of BioPharma Life Science equipment, regulatory cGMP knowledge.
About Us:
IPS, a Berkshire Hathaway Company, is a global leader in developing innovative business solutions for the biotechnology and pharmaceutical industries. Through operational expertise and industry-leading knowledge, skill, and passion, IPS provides consultancy services, architecture, engineering, project controls, construction management, and compliance services that allow clients to develop and manufacture life-impacting products.
Its newest acquisition, Linesight, specializes in cost, schedule, risk, program, and project management services in various market sectors, including data centers, life sciences, and high-tech industries. With the addition of Linesight, IPS has over 3,000 professionals in over 45 offices across 17 countries in the Americas, Europe, Asia Pacific, Southeast Asia, Australia, and the Middle East.
Specialties
Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV and Staffing Services.
All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.
IPS is proud to be an affirmative action and equal opportunity employer.
Attention Search Firms / Third-Party Recruiters: IPS is not seeking assistance or accepting unsolicited resumes from search firms for employment opportunities with IPS. Regardless of past practice, all resumes submitted by search firms to any employee at IPS via email, the Internet, or directly to hiring managers at IPS in any form without a valid written search agreement in place for a specific position will be deemed the sole property of IPS, and no fee will be paid in the event a candidate is hired by IPS as a result of the referral or through other means.
#LI-TF1
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