Principal Manufacturing Systems Engineer
2 weeks ago
Job Description
\Amgen is committed to serving patients with serious illnesses. We are seeking a collaborative individual contributor leader to join our team as a Principal Manufacturing Systems Engineer.
\This role will involve leading the execution and successful delivery of varied portfolios of IS/Automation projects, including scope definition, technical leadership, budget estimate and management, reporting, vendors engagement, and project issue resolution.
\The ideal candidate will have a Doctorate degree in Engineering and 2 years of combined Information Systems and Manufacturing Process Automation experience, or equivalent qualifications.
\Required Skills and Qualifications
\- \
- Doctorate degree in Engineering and 2 years of combined Information Systems and Manufacturing Process Automation experience\
- Or Master's degree in Engineering and 4 years of combined Information Systems and Manufacturing Process Automation experience\
- Or Bachelor's degree in Engineering and 6 years of combined Information Systems and Manufacturing Process Automation experience\
- Engineering, Information Systems, Computer and/or Software GMP-regulated industry background with experience leading projects and resources\
- 8+ years of experience in manufacturing, including 5+ in Pharma/Biotech industry\
- Strong analytical and problem-solving skills\
- Excellent communication and interpersonal skills\
- Able to work effectively in a team environment\
- Ability to translate strategic opportunities and emerging technology solutions into tangible pragmatic executable plans\
- Effectively manage relationships with Peers, IS service owners, business partners, enterprise IS service partners, and vendors\
- Communicates with multiple levels within the organization, highlighting issues and proposing solutions\
- Accountable for end-to-end Technology projects delivery from the business case creation up to qualification and go live into manufacturing production\
- Scope definition, technical leadership, budget estimate and management, reporting, vendors engagement, and project issue resolution\
- Project planning, resource allocation, risk management, and financial management for the portfolio\
- Manage multiple initiatives and priorities\
- Anticipate, evaluate, and resolve multiple simultaneous project issues, delays, and problems by utilizing technical, project management, and business expertise\
- Cross-system analysis, feasibility analysis, scope projects, prioritize deliverables, and recommend optimal solution\
- Perform cross-system analysis, feasibility analysis, scope projects, prioritize deliverables, and recommend optimal solution\
- Proactively identify and mitigate risks associated with projects\
- Develop and maintain strong working relationships with internal stakeholders, including senior leadership, subject matter experts, and other functional teams\
- Identify opportunities to improve process efficiency and implement changes that drive results\
- Conduct thorough root cause analysis on complex issues and develop corrective action plans to address them\
- Act as a thought leader in the development and implementation of innovative technologies and processes\
- Participate in ongoing education and training to stay current on industry trends and best practices\
- Advise and guide junior engineers and technicians to develop their skills and knowledge\
- Collaborate with other departments and teams to ensure alignment and seamless execution of projects\
- Support organizational goals and objectives by participating in special projects and task forces as assigned\
- Other duties may be assigned based on business needs\
- Strategic thinking and ability to analyze complex problems and develop effective solutions\
- Experience working in a dynamic and fast-paced environment\
- Flexibility to adapt to changing priorities and deadlines\
- Excellent written and verbal communication skills\
- Ability to build strong relationships with colleagues and stakeholders at all levels of the organization\
- Results-oriented with a strong focus on delivering high-quality results\
- Ability to work independently and collaboratively as part of a team\
- Technical leadership and collaboration skills\
- Business acumen and ability to communicate complex technical concepts to non-technical stakeholders\
- Customer-centric approach and ability to prioritize customer needs and expectations\
- Strong analytical and problem-solving skills, with a focus on root cause analysis and corrective action planning\
- Teamwork and collaboration skills, with a focus on building strong relationships with colleagues and stakeholders\
- Effective time management and prioritization skills, with a focus on meeting deadlines and delivering results\
- Continuous learning and professional development skills, with a focus on staying current on industry trends and best practices\
- Interpersonal and communication skills, with a focus on building trust and credibility with colleagues and stakeholders\
- Strong business judgment and decision-making skills, with a focus on making informed decisions that drive business outcomes\
- Business agility and adaptability, with a focus on being responsive to changing priorities and deadlines\
- Leadership skills, with a focus on developing and empowering others to achieve their full potential\
- Coaching and mentoring skills, with a focus on helping others to grow and develop professionally\
- Networking and relationship-building skills, with a focus on building strong connections with colleagues and stakeholders\
- Process improvement skills, with a focus on identifying and implementing process efficiencies that drive results\
- Root cause analysis and corrective action planning skills, with a focus on resolving complex issues and improving processes\
- Communication and presentation skills, with a focus on effectively conveying complex information to various audiences\
- Time management and prioritization skills, with a focus on balancing competing demands and achieving results\
- Professional certification(s) relevant to field such as Six Sigma Black Belt, Certified IT Project Manager (CIPM), etc.\
- Leadership and management certifications such as PMP, Six Sigma Black Belt, Agile Certification, etc.\
- Active participation in industry conferences and networking events to stay current on industry trends and best practices\
- Development and maintenance of strong relationships with internal stakeholders, including senior leadership, subject matter experts, and other functional teams\
- Regularly assess and refine personal skillset to meet evolving business needs\
- Self-motivated and proactive approach to pursuing personal and professional development\
- Stay up-to-date with industry developments and trends through self-directed research and continuous learning\
- Seek out and participate in training and development opportunities to enhance skills and competencies\
- Collaborate with peers to share knowledge and best practices\
- Represent Amgen externally through presentations, publications, or speaking engagements, as needed\
- Make sound judgments and recommendations regarding design, engineering, and implementation of new technologies and equipment\
- Develop, document, and maintain standards, policies, procedures, and guidelines related to Engineering, Quality Assurance, and Regulatory Compliance\
- Design, develop, and implement quality metrics and monitoring programs to measure system performance\
- Develop and execute comprehensive testing strategies to validate product quality\
- Evaluate system effectiveness using statistical methods and tools\
- Document and present test results to assure compliance with regulatory requirements\
- Collaborate with development team members to plan, schedule, and execute validation activities\
- Implement deviation control and investigation methodologies to minimize risks associated with system failures\
- Deliver periodic audits and surveys to ensure proper system function and user acceptance\
- Provide technical guidance and support to customers in trouble-shooting and resolving issues\
- Develops short-term and long-range goals, priorities, and objectives; establishes measurable criteria for success\
- Responsible for securing funding to sustain future growth and stability\
- Presents reports to higher management explaining successes and setbacks\
- Maintains accurate records and analyses data to inform operational decisions\
- Can conduct cost/benefit analyses and uses this information to justify discretionary spending\
- Has experience creating budgets and managing funds efficiently\
- Maintain open communication lines between departments to ensure smooth day-to-day operations\
- Ensures security protocols are met and implemented according to industry standards\
- Assists in scheduling workflow and assigning tasks to maximize efficiency and productivity\
- Establishes changeover procedures to reduce waste and increase productivity\
- Improves existing methods for providing excellent customer satisfaction\
- Maximize employee potential through goal-setting, positive reinforcement, coaching, and feedback\
- Understand and adheres to laws, regulations, and ethical codes governing employment practices\
- Continuously evaluates staff performance and provides timely recognition and feedback\
- Organizes regular meetings to keep employees updated on company news and projects\
- Builds, maintains and communicates a shared vision and mission to drive departmental success\
- Provides clear direction and support to team members and managers\
- Encourages active collaboration among team members\
- Supervises and directs subordinate staff, including job assignments, performance evaluation, coaching, and discipline when necessary\
- Administers payroll and personnel functions to include employee relations, staffing, recruitment, compensation, benefits, talent management, succession planning, performance management, employee engagement, employee retention, and benefits administration\
- Accomplishes assigned goals and objectives of the organization while keeping up with industry trends and outlook\
- Serves as an internal consultant to senior management on human capital matters\
- Manages grievances, disputes, and settlements\
- Advises senior management on organizational structure, reorganization, rightsizing, and downsizing efforts\
- Ensure compliance with applicable labor laws, collective bargaining agreements, policies and procedures\
- Delegate responsibilities appropriately to obtain desired outcomes\
- Identifies areas for process improvements and develops recommendations for the same\
- Leads and participates in the development of the annual operating plan and ensures its successful execution\
- Measures and analyzes overall employee performance and makes recommendations for rewards and recognition\
- Oversees all aspects of recruitment, selection, hiring and placement\
- Provides recommendations to senior management for organizational design, workforce planning, talent development, succession planning, and performance management\
- Reviews, evaluates, and revises HR policies, procedures and practices\
- Develops and manages budgets, expenditures, and asset utilization\
- Investigates employee complaints and takes corrective actions as required\
- Coordinates training programs for both supervisory and non-supervisory employees\
- Works closely with IT and other departments to manage software applications and systems used across departments\
- Administrative assistance to all levels of Management\
- Maintains high visibility and accessibility within the workplace\
- Acts as liaison between different departments\
- Formulates and implements sustainable processes to create value-added services and improved guest experiences\
- Implements Kaizen initiatives to continually improve the efficiency and effectiveness of all HR-related processes\
- Recognize and celebrate employee milestones and achievements\
- Enhance employee morale and motivation\
- Harmonize employee retention and turnover rates with productivity and profitability goals\
- Develop and maintain transparent, inclusive, and respectful workplace environments\
- Empower employees to provide exceptional guest experiences\
- Be culturally sensitive and diplomatically capable of handling diverse cultural and language differences\
- Handle miscellaneous HR requests promptly and accurately\
- Plan, coordinate, and execute numerous events and campaigns\
- Facilitate one-on-one coaching sessions for direct reports to discuss career development and goals\
- Hold monthly town hall meetings to engage employees\
- Partner with Team Leaders to recognize outstanding performers and create award packages\
- Follow and enforce corporate policy and adhere to Federal and State Labor Laws\
- Conduct exit interviews to gauge employee satisfaction\
- Build strong relationships with government agencies, unions, and community organizations\
- Embark on diversity, equity and inclusion initiatives to amplify representation and inclusion\
- Work cooperatively with all departments to promote teamwork and collaboration\
- Expand access to Employee Benefits\
- Prepare budget for Overtime Approval annually\
- Partnerships with Agencies to expand talent pools\
- Department heads may also partner with me on targeted agendas to get synergistic output\
- Ongoing Communication Strategies with Department Heads\
- Review reports to monitor progress toward established goals\
- Advocate for employee interests and concerns to upper management\
- May delegate specific Human Resources responsibilities to supervisor/department heads when appropriate\
- Inspect facilities regularly to ensure cleanliness and adherence to safety policies\
- And many more...
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