Site Mechanical & HVAC Engineer

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.

Total Rewards : Compensation & Benefits

Spark® offers a competitive, flexible, and comprehensive Total Rewards package that can be customized to fit your personal needs.

Our program is designed to support the holistic wellbeing of employees and their families by providing health coverage, retirement savings plan, and a range of voluntary benefits for financial protection and peace of mind.

For all employees, our core total rewards package includes industry competitive salaries; bonus eligibility; and long-term incentive eligibility, including both new hire and annual grant opportunities.

We do everything we can to make working at Spark rewarding for you.

Your Health & Wellbeing

• Medical and Prescription Drugs
• Dental and Vision
• Health Advocate
• Health Savings Accounts (HSA)
• Flexible Spending Accounts (FSA)

Your Financial Protection

• 401(k) Retirement Savings Plan
• Financial Planning
• Life and Disability Insurance
• Identity Theft Protection
• Discounted Pet, Auto, and Home Insurance

Your Work / Life Balance

• Time Away from Work Paid Time Off (PTO) Use for vacation, illness or personal timeHolidays Observance of up to 12 designated holidays, two floating holidays, plus a winter shutdownVolunteer Days Up to two volunteer days per yearSpark Unplugged Half Days Designated alternate half day Fridays year-roundPaid Parental Leave Fully paid pregnancy leave up to 16 weeks total for birth mothers and up to eight weeks for parents
• Mental Health Support Program which includes coaching and therapy
• Employee Assistance Program (EAP)
• Tuition Reimbursement Program
• Mobile Phone Allowance
• Company Paid Commuter Program
• Adoption Assistance Program
• Care@Work Membership
• LifeMart Discount Program

that are made available in response to the federal Transparency in Coverage Rule and includes negotiated service rates and out-of-network allowed amounts between health plans and healthcare providers.

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