Responsibilities:
- Responsible for compliance with applicable policies and procedures; ensure quality and effectiveness of key results through sound design, early risk assessments, and fallback strategies.
- Independently plan and conduct high business impact projects in Drug Product Manufacturing or Packaging; achieve financial targets; maintain project controls and reporting for cost, scope, and schedule.
- Develop execution strategy including procurement; balance multiple demands; understand customer needs and cGMP requirements; incorporate emerging technology trends.
- Serve as Facility, Equipment, and Utilities SME during Regulatory Agency audits; prepare documentation packages and present information to regulatory agents.
- Produce unique, cost-effective results; create/modify designs for intermediate problems; integrate financial and technical data; analyze complex interdisciplinary problems and draw conclusions reflecting broad business needs.
- Represent engineering on corporate task forces; identify customer/client needs and propose solutions; may supervise other engineers or technicians.
Qualifications:
- Bachelorβs degree in Engineering, science, or closely related discipline (desired) or equivalent technical experience plus demonstrated competence; 6+ years of significant engineering and/or operational experience (post-graduate degree desired).
- Demonstrated competency within a discipline.
- Strong technical knowledge and application of concepts, practices, and procedures; ability to work complex-scope problems with multiple factors; judgment within defined procedures.
- Ability to interact with diverse groups; communicate tactfully and respectfully in oral/written/presentation formats.
- Interpersonal skills to negotiate and reconcile differences in a fast-paced, goal-driven environment.
- Technical background in healthcare, medical devices, pharmaceuticals, biologics, or similar industries (preferred).
- Demonstrated competency with financial systems and fiscal control.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) (eligible employees).
- Eligible to participate in short-term incentive programs.