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SeniorEngineerManager- Upstream
Remote / Online - Candidates ideally in
Holly Springs, Wake County, North Carolina, 27540, USA
Listed on 2026-06-02
Holly Springs, Wake County, North Carolina, 27540, USA
Listing for:
BioSpace
Remote/Work from Home
position Listed on 2026-06-02
Job specializations:
-
Engineering
Operations Manager, Manufacturing Engineer
Job Description & How to Apply Below
Senior Engineer Manager – Upstream
Responsible for the department capital portfolio and project management of small capital projects at the drug substance facility in ANC.
What You Will Do- Provide technical leadership to a team of manufacturing support engineers supporting commercial production operations with emphasis on drug substance bioprocessing equipment.
- Establish clear expectations, priorities, and a culture of continuous improvement and knowledge sharing; provide development opportunities and actively listen to staff.
- Build and maintain a culture of safety, reducing safety risks for all staff members.
- Provide technical support to troubleshoot, identify, and resolve process and system issues.
- Ensure compliance and regulatory aspects for equipment validation, operation, and maintenance.
- Collaborate with key customers and support groups (Manufacturing, Quality, Process Development, Maintenance, network partners).
- Ensure all tasks and projects are accomplished safely.
- Employ business analytics to assess performance and identify improvement opportunities.
- Lead sustainability program management of cross‑functional initiatives.
- Collaborate with leadership to set strategy and business objectives.
- Foster and maintain relationships with key stakeholders.
- Establish a balanced scorecard of KPIs to monitor equipment performance, sustainability, and reliability programs.
- Develop action plans to address performance gaps or opportunities.
- Communicate gaps and establish proper escalation processes.
- Identify opportunities to optimize organizational efficiency.
- Lead engineering and contractor evaluation and selection processes.
- High school diploma / GED and 12 years of engineering and/or project management experience OR
- Associate’s degree and 10 years of engineering and/or project management experience OR
- Bachelor’s degree and 8 years of engineering and/or project management experience OR
- Master’s degree and 6 years of engineering and/or project management experience OR
- Doctorate degree and 2 years of engineering and/or project management experience.
- Minimum of 2 years of direct people‑management or leadership experience leading teams, projects, or programs.
- Bachelor’s degree in chemical engineering or a related technical field.
- 5+ years of engineering experience in a manufacturing support environment with 3+ years in the pharmaceutical or biotechnology industry.
- Demonstrated people‑management/leadership experience.
- Experience with mammalian cell culture, protein purification, clean utilities, CIP, SIP, and production services; upstream unit operation experience such as bioreactor or harvest equipment.
- Familiarity designing, troubleshooting, and operating equipment used in cell culture manufacturing, including disposable technologies.
- Experience with tech transfer, process design, and commissioning & qualification.
- Experience with validation and change control methodology.
- Direct experience in regulated environments (cGMP, OSHA, EPA) and detailed understanding of cGMPs.
- Excellent written and verbal communication skills.
- Demonstrated interpersonal and facilitation skills, and ability to work in a collaborative team‑based environment.
- Analytical skills to evaluate and interpret complex problems using multiple data sources.
- Ability to lead and influence cross‑functional teams and embrace a team‑based culture.
- Familiarity with designing and operating equipment used in biopharmaceutical manufacturing.
- Experience applying operational excellence and Lean manufacturing principles.
- Comprehensive employee benefits package: retirement and savings plan with generous company contributions, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
- Discretionary annual bonus program; sales‑based incentive plan for field sales representatives.
- Stock‑based long‑term incentives.
- Award‑winning time‑off plans and bi‑annual company‑wide shutdowns.
- Flexible work models, including remote work arrangements when possible.
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will provide reasonable accommodation to individuals with disabilities for participation in the application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
#J-18808-LjbffrPosition Requirements
10+ Years
work experience
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