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Site Mechanical

4 months ago

Philadelphia, United States Spark Therapeutics Full time

Join the Spark Team

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to unlock the power of gene therapy to accelerate healthcare transformation.

We don't follow footsteps. We create the path.

Primary Duties

Site Mechanical & HVAC Engineer reports into the Director of Engineering & FEED and will provide Technical Engineering support and oversight for Spark Facilities GxP and Non-GxP Mechanical and HVAC systems. This role will primarily provide engineering support to Spark developing design and executing new equipment / system implementations, future equipment / system modifications, supporting large and small CAPEX projects, continuous improvement activities, advanced day to day troubleshooting and operational support as needed.

The Mechanical & HVAC Engineer - will be responsible for the following key tasks:

* Ensure that engineering design and maintenance strategy, consider loss elimination and risk management.
* Provide Subject Matter Expertise (SME)
* Evaluate conceptual aspects of technical Site / Facility designs to ensure sound decisions and investments are made in accordance with business strategy and internal policy/governance.
* Challenge internal design and/or external supplier technical data, recommendations, and operability to ensure Reliability, Maintainability, and Availability minimum requirement targets are met.
* Routine day to day support to spark sites, operations teams and other departments.


* Support large CAPEX projects and deliverables through Basic Design, Detailed Design, Execution and Operational phases of those projects. Meet scheduled milestones to ensure operations or project/program objectives are met in a timely manner.
* Liaise with other Spark Engineering departments, Facilities/Maintenance and Operations teams to support site optimizations / changes, tech transfers, CAPA's or quality related changes, root cause investigations and advanced troubleshooting as needed.
* Organize and lead Mechanical & HVAC commissioning and qualification, including development and execution of any associated protocols and reports.
* Own lifecycle maintenance of Mechanical & HVAC engineering drawings, documentation, specifications, standards and reports.
* Support the development and lifecycle management of Standard Operating Procedures (SOPs), Preventative Maintenance Plans, and Logbooks for equipment / system set up and operation.
* Create associated training materials and provide training for internal operations and maintenance team as needed.
* Collaborate with numerous teams within Spark (Manufacturing, Digital Systems, MS&T, R&T, AQC, Process Development, and Quality) to ensure all facility and site capabilities are delivered maintained and supported in accordance to Spark principles, policies and standards
* Provide Subject Matter Expert (SME) knowledge as required on process within the area of responsibility.
* Support the overall CQV process, in part by being the lead and SME for DRDQ and FCCA documentation, development and execution.
* Provide daily and direct Mechanical & HVAC support to Spark operations.
* Lead investigations as applicable.
* Other duties as assigned.

Responsibilities

Provide day to day / routine technical HVAC & Mechanical equipment / system operations and project support for Spark.

* Cross functionally collaborate with other engineering functions as needed for routine troubleshooting (Digital Systems, Clean Utilities, etc.)
* Author / and Review deviations pertaining to Mechanical & HVAC systems and support impact assessments for Sparks Site / Facilities as applicable.
* Lead Root Cause Analysis and Risk Assessment Programs and address gap assessments for Spark Scientific, Technical and Manufacturing Operations.
* Support reviews of any Change Controls, Validation protocols, and CAPAs. Collaborate with operations teams on CAPA effectiveness.
* Manage on-time approval and closure of these quality records.
* Own Engineering Records, drawings, specifications, standards for Mechanical & HVAC systems.

Site Engineering Core Team member responsible to support of activities related to the Mechanical & HVAC support functions aspects.

* System Owner for Mechanical & HVAC equipment specification and design.
* Identify changes to improve design in a cGMP environment.
* Own Small CAPEX projects, develop and implement process improvements / optimizations or continuous improvements.
* Provide Subject Matter Expert (SME) knowledge as required on process within the area of responsibility.
* Support the lifecycle Validation process, in part by being the site lead and SME for DRDQ and FCCA documentation, development and execution.
* Attend and execute equipment Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) at vendor sites and Spark site(s).

Act as a liaison between Spark Operations, Clean Utilities, Automation Engineering and Capital project teams for large CAPEX projects, tech transfers and Site / Facility optimizations.

* Support Large Capex Projects as Mechanical & HVAC system(s) owner.
* Participate as System owner support in analysis of Site / Facility performance.
* Support cross functional teams in analysis of technically Site / Facility design concepts, methods and standards to be implemented at site.
* Provide support to Regulatory for authoring relevant sections of submissions and to Quality for deviation investigations, CAPAs and change controls.
* Manage contract and internal resources to execute site related capex projects ranging up to $10MM in accordance with site priorities and company initiatives / goals.

Education and Experience Requirements

* BS or MS (MS preferred) Engineering degree in a relevant field or area of specialization (Mechanical / Industrial engineering)
* 10 plus years' experience in cGMP Biotechnology, pharmaceutical or equivalent Engineering Service oriented industry.
* Development and lifecycle maintenance of Engineering Records, Standard, Specifications and Drawings.
* Experience working within a BSL-2 environment.
* Experience with Mechanical and HVAC Systems including supporting Facilities Infrastructure. (HVAC Systems, Fans, Pumps, Boilers, chillers, cooling towers, hydronic systems etc.)
* Experience with Cleanroom Design a plus.
* Up to 10% travel required.
* Previous Mechanical & HVAC equipment / system commissioning, qualification, validation experience.
* Previous experience leading the DRDQ and FCCA efforts.
* Mechanical & HVAC Equipment troubleshooting, testing, startup/turnover, lifecycle maintenance experience.
* Experience with FDA, USP, ICH, EMA, ISPE.
* Demonstrated ability to lead investigations, study execution, and produce high quality technical documentation.
* Proven track record in a CAPEX program environment.

Spark takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary for potential new employees. The base salary range for this position is currently from $121,300 to $181,900.

Spark Therapeutics does not accept unsolicited resumes/candidate profiles from any source other than directly from candidates. Any unsolicited resume/candidate profile submitted through our website or to personal email accounts of employees of Spark Therapeutics are considered property of Spark Therapeutics and are not subject to payment of agency fees.