West Pharma Specialist Technology Operations 

United States, Pennsylvania, West Whiteland Township 

181103124

Job Summary:

In this role, the Technology Operations Specialist is responsible for managing the project lifecycle, from initiation to project close, for laboratory projects within West Services and Solutions. The Technology Operations Specialist leads projects as assigned by the Manager, Technology Operations and ensures a project is defined, planned, executed, and closed per the laboratory PMO process and requirements. This role operates within the regulatory confines of a GMP pharmaceutical and medical device testing laboratory and must ensure all projects meet the applicable regulatory expectations.

Essential Duties and Responsibilities:

• Safety and Compliance: Responsible for ensuring all relevant safety practices and procedures are employed. Responsible for ensuring cGMP regulations and QA procedures are adhered to for all relevant work.

• Opportunity Evaluation: Support project or business opportunities in concept and present findings in a way that provides lab leadership with actionable decision-making information.
• Project Planning: Lead project planning activity and develop comprehensive project plans including scope, timelines, budget, resource allocation and project success criteria. Gain buy-in from project team and ensure an inclusive approach to project planning.
• Risk Management: Proactively identify risks to project success and implement mitigation strategies to minimize impact.
• Coordination: Collaborate with cross-functional teams, internal and external to the laboratory, to coordinate project execution and ensure that project objectives and success criteria are met.
• Resource Management: Manage project budgets, scope, resources, and timelines effectively to optimize project outcomes. Identify gaps and changes and ensure stakeholder and resource manager alignment on current project needs.
• Documentation and Reporting: Maintain accurate and detailed project documentation per laboratory PMO requirements. Ensure stakeholder and management visibility to project progress, achievements, issues, barriers, and risks. Ensure project updates are made in relevant systems and/or forums.
• Compliance Oversite: Ensure all project activities adhere to cGMP guidelines and relevant regulatory requirements. Ensure project lifecycle compliance to the laboratory PMO process. Conform with and abide by all regulations, policies, standard operation procedures and instructions, and all safety rules.
• Continuous Improvement: Ensure a robust After-Action Report (AAR) is performed after each project completion and process strengths and weaknesses are identified. Assist in planning and execution of continuous improvement activity revolving around the laboratory PMO process.
• Other duties as assigned

Basic Qualifications:

• Bachelor’s Degree in a Related Technical or Business Field or equivalent experience.

Work Experience:

• 3+ years’ experience in a technical or project management roles within a pharmaceutical, medical device or biotechnology laboratory.
• Demonstrated competence in defining, planning, and executing projects.
• Basic knowledge of general laboratory operations and analytical instrumentation.
• Strong communication and interpersonal abilities, with the capacity to communicate complex technical concepts to diverse stakeholders.
• Excellent organizational and leadership skill, with the ability to prioritize tasks, delegate responsibilities, and motivate cross-functional teams to achieve project objectives.
• Proficiency is standard project management tools and software (e.g. Microsoft Project, Excel) for planning, tracking, and reporting project activities.
• Detail-oriented mindset with a focus on quality and compliance, coupled with the ability to adapt to changing priorities and deadlines in a fast-paced contract laboratory environment.
• Proficiency with MS Office products (Word, PowerPoint, Outlook)

Preferred Knowledge, Skills and Abilities:

• Professional Project Management Certification (e.g. PMP)

• Experience with Microsoft Azure DevOps
• Experience with regulatory inspections and audits.
• Experience working within an established corporate PMO process.
• Able to comply with the company’s safety and quality policies at all times

Travel Requirements:

• Must be able to travel up to 5% of the time

Physical Requirements:

• • • Sedentary - exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to life, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met

Additional Requirements:

• Maintain the ability to work well with others in a variety of situations.
• Able to multi-task, work under time constraints, problem solve, and prioritize.
• Able to maintain confidentiality and resolve conflicts.
• Observe and interpret situations, analyze and solve problems
• Learn and apply new information or new skills
• Work under deadlines with constant interruptions
• Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Position operates in a professional office environment. May stand or sit for extended periods of time
• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read & write, speak in front of groups, express & exchange ideas, understand direction and adhere to procedures
• Organizational skills will enable planning, prioritization & achievement of goals especially of importance for the successful execution of related activities
• Read and interpret data, information and documents
• Ability to make independent and sound judgments