Senior Engineer

Our Frederick Manufacturing Center (FMC) creates life-changing medicines for people around the world and has been recognized by our local community as being a Top 50 Business in Frederick and awarded Frederick Countys Best Place to Work. This distinctive biologic manufacturing facility with over 800 employees makes a direct contribution to treating people with cancer respiratory and autoimmune conditions across the globe. We work hard to deliver life-changing medicines to patients and we take time to have fun and celebrate our accomplishments. From catered site festivities to competitive events community outreach activities environmental and wellness showcases and team-building functions we take time to recognize our achievements and celebrate our diversity. We are dedicated to creating a culture of inclusion and collaboration and are committed to continuous learning by offering ongoing skill building and training for our staff. Fueled by our aspiration to deliver accelerated growth for our company and to make peoples lives better theres never been a more exciting time to join the team and shape the future of AstraZeneca Operations.

Accountabilities:

Lead operations troubleshooting and lifecycle management of HVAC water pretreatment WFI pure steam OFCA clean air specialty gases cold rooms/freezers boilers hot water heating chilled water systems glycol systems chillers bio-safety cabinets and other GMP or non-GMP systems to ensure compliance reliability and capacity alignment with production needs.

Provide engineering project support for clean utilities and clean room qualification activities including document review approval and support of project execution.

Deliver medium-sized capital projects from concept through executiondevelop scopes URS budgets schedules risks procurement strategies and commissioning/qualification. Responsible for managing project lifecycle presentations and reporting to senior leadership via stage-gate reviews.

Communicate project status and risk to stakeholders.

Collaborate with cross functional groups and stakeholders including Manufacturing Quality Validation SHE Supply Chain and Procurement

Lead vendors/contractors to carry out projects and/or services.

Responsible for supporting audits and regulatory inspections.

Identify and implement energy efficiency and carbon reduction projects (e.g. heat recovery HVAC optimization advanced controls utility load management water reduction compressed air optimization) tracking performance via KPIs and dashboards.

Ensure systems meet GMP FDA internal quality standards and documentation control across utilities and facilities systems.

Use Siemens Insight (including PPCL) Rockwell Automation and Emerson DeltaV to collect data troubleshoot perform trend analysis optimize control sequences and implement changes per validated procedures and change control requirements.

Write and manage deviations root cause analyses CAPAs Change Controls Risk Assessments Mitigation Actions and EMIR/UIRs ensuring timely closure effectiveness verification and robust technical documentation.

Author and update SOPs preventive maintenance procedures calibration plans and spare parts lists to maintain compliance operability and inspection readiness.

Lead RCM-based programs including criticality assessments FMEA PdM technologies (e.g. vibration IR oil analysis signals analysis) spare parts optimization and PM strategy refinement to improve mean time between failure and reduce lifecycle cost.

Essential Skills / Experience

-Bachelors degree in Mechanical Chemical Electrical or Industrial Engineering or equivalent experience.

-4 years in pharmaceutical/biotech or highly regulated manufacturing facilities engineering.

Proven track record delivering capital projects up to $5M from concept through CQV in an FDA-regulated environment.

Desired Skills/ Experience

-Masters Degree

-8yrs in pharmaceutical/biotech or highly regulated manufacturing facilities engineering

The annual base pay (or hourly rate of compensation) for this position ranges from $101643.20 to $152464.80 Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors including market location job-related knowledge skills and addition our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) to receive a retirement contribution (hourly roles) and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program 401(k) plan; paid vacation and holidays; paid leaves; and health benefits including medical prescription drug dental and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired employee will be in an at-will position and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and furtherance of that mission we welcome and consider applications from all qualified candidates regardless of their protected characteristics. If you have a disability or special need that requires accommodation please complete the corresponding section in the application form.