Maintain P & L responsibility with associated commercial and financial accountability including revenue delivery, margin and overhead management, budget and forecast determination and attainment, risk and opportunity reviews, cost controls, accounts payable/billing and cash collection
Contributes to and reviews the project proposal and plan to determine timeframe, procedures for accomplishing the project, staffing requirements, and allotment of available resources to various phases of the project
Contributes to setting project evaluation parameters.
Follows Change Management process to proactively identify, assess, and approve modifications to scope, cost, and schedule.
Pursue and develop opportunities for innovation, such as digitalization and technology use, workshare and high value engineering centers, to bring value to Wood and customer
Establishes project procedures and leads production of project execution plan including the scope of work, deliverables list, master schedule, budget, org charts, risk register etc
Regularly reports project progress to senior management and/or the customer.
Responsible for delivery of agreed schedule and financial performance, proactively intervening to avoid slippage
Ensures competence of project team members to carry out assigned work
Interface with discipline department managers on needs, mobilization and demobilization of resources
Leads ongoing focus on risk identification and mitigation during project execution
Define the Resource plan and enable facilitate the communication between QA, Operations and Supply Chain
Coordinate the different Testing activities from Media runs through PV
Understand of Industry Standards and their applicability on the project
Process knowledge on Pharmaceuticals and Biopharmaceuticals
Experience with ISA 88, 95 and 99
Familiar with MES projects and systems such as PharmaSuite, PAS-X and Syncade
Familiar with Sterile projects and environments
Oversee SAP-MES interface integration, report development, and L2 integrations.
Ensure compliance with industry standards (21CFR Part 11, GAMP, cGMP, EU Annex 11) and perform Computer Systems Validation (CSV)
Adaptability and Flexibility to changing requirements and environments
Leadership
Is a champion and role model for ethical behavior and compliance with applicable laws and Policies.
Leads by example, focuses on supporting others to achieve project success
Oversees proposals and call-offs (may be individual projects) within delegation of authority, ensuring compliance with contracting policy and standards of ethical conduct.
Coaches, mentors, and empowers others to make decisions within established parameters
Ability to work on ambiguous environment
Working Relationships
Primary point of contact for customer on assigned scope. Establishes and maintains a positive and effective customer relationship, ensuring payment terms are met, and communicating any potential or identified problems/delays
Manage relationships with external suppliers and sub-contractors and resolves cost, schedule and quality issues
Builds internal and external relationships, maintaining focus on being positive and growth-oriented
May act as company representative and play a role in contract negotiations
Influences relationships at higher customer level
Strong Stakeholder management skills
QUALIFICATIONS
Knowledge, skills, and experience:
A Bachelor's degree in the field of Engineering or similar technical degree
5+ years of Life Sciences industry experience including minimum 2-3 years' experience as the Project Manager for projects, mastering their technical area and knowledgeable about impacts and dependencies on other areas.
Thorough understanding of project management techniques and practices
Thorough understanding of project goals, drivers, strategies, stage gate processes, and schedules
Thorough understanding of Agile framework
Proficient in the use of MS Office 365 products
Good communication skills, both verbal and written
Good presentation skills
Experience with scheduling software (MS Project, Primavera P6)
Experience with CAD a plus
Professional Engineering License (P.E.) a plus
Project Management Professional (PMP), Associate in Project Management (APM) or equivalent certification is preferred
