Partner Therapeutics

DIRECTOR, SITE ENGINEERING/FACILITIES (ONSITE)

POSITION SUMMARY

The Director, Site Engineering/Facilities, is a key member of the Northpointe leadership team. The Director is responsible for the reliable operation, maintenance, and continuous improvement of the Site’s infrastructure, utilities, equipment, and facilities in support of cGMP, API manufacturing. This Leader ensures that critical systems, including building infrastructure, clean and plant utilities, HVAC, automation, and laboratory and process equipment remain in a ready state, complaint, and fit for purpose.

Reporting to the Northpointe Site Head, this position oversees the Maintenance, Metrology, Automation, Asset Management, Facilities, Security, and HSE functions. The Director works cross-functionally to support capital project execution, drive life cycle management initiatives, maintain site and equipment audit and inspection readiness, and contributes to long-term site planning and operational excellence.

KEY RESPONSIBILITIES

Functional:

• Leads daily operations for Facilities Engineering, Metrology, Automation, Asset Management Systems (AMS), Security, and HSE at the Northpointe API manufacturing site.
• Ensures reliable, compliant, and cost-effective performance of all site utilities, equipment, and infrastructure through proactive maintenance and life cycle management strategies.
• Develops and manages departmental goals, capital and operating budgets, staffing plans, resource prioritization and performance metrics aligned with site and corporate objectives.  Ensures capabilities and capacity are in place to effectively deliver on all departmental commitments and performance targets.
• Provides technical oversight and strategic direction for facilities and equipment related capital projects, renovations, and upgrades using Good Engineering Practices (GEP).
• Serves as a key stakeholder in inspection readiness activities, deviation investigations, CAPAs, and change control for facilities and equipment.
• Reviews, approves, and enforces procedures for the management of assets and ensures the facility is safe, operational, productive and secure.
• Promotes and fosters a strong culture of safety, compliance, collaboration, and service across all engineering-related functions.
• Represents the Engineering Services team on the Site Leadership Team, Operational Leadership Team, Quality Council, Project Management Board, and other cross-functional forums.
• Oversees and contributes to the creation of policies, procedures, standards, and controls to enhance the support and adherence to U.S. and applicable international GMP regulatory agencies.
• Oversees development of emergency response, disaster recovery, and business continuity plans.
• Works in collaboration with Site Leadership in emergency response, disaster recovery and business continuity incidents.
• Participates in the development and prioritization of the Organization’s/Site’s Life Cycle Management Plan.
• Adheres to all applicable regulations and requirements including compliance with internal SOPs, GMP, Health and Safety, WISHA/OSHA, regulatory compliance, Company policies, and employment-related laws and statutes.
• Successfully completes all mandatory Quality and Compliance training within the required timeframes.
• Resolves “stuck” issues by ensuring timely issue escalation to Leadership and cross-functional teams: Applies learning from these events and leads the creation of new/updated systems, processes, programs to prevent similar situations in the future.
• Through self-education and external networking/participation in industry and professional organizations keeps abreast of current industry trends, compliance requirements, and best-of-class technologies relating to area of responsibility. Actively applies learned best practices, knowledge, and benchmarking to PTx projects and solutions.
• Pursues participation or leads project teams outside normal course of work (i.e. “collateral duties”) as they become available to support personal growth, connection, and business needs.
• This job description is not intended to be all-inclusive. Partners may be required to perform other related duties as required to meet the ongoing needs of the organization.

PEOPLE LEADERSHIP

• Establishes departmental and individual goals and objectives in alignment with Site goals and priorities.  Identifies performance improvement targets and metrics. Ensures capabilities and capacity are in place to effectively deliver on all departmental commitments and performance targets.  
• Recommends and allocates resources - human, financial, technical, etc. - to fulfill near and long-term goals and commitments while building towards sustainable excellence.
• Builds, develops, inspires, motivates, and leads a diverse, professional team. Sustains high performance that is strongly aligned and coordinated with other functional groups across the organization; ensures Partner engagement by creating a culture of inclusion, execution, and an environment within which they can excel and continuously improve.
• Works proactively and in close collaboration with upline Leadership Team and People & Culture to recruit, hire, grow, and retain a diverse team of talent.
• Manages and develops the performance of direct reports by setting clear SMART goals, provides and seeks timely performance feedback, recognizes and rewards high achievers, and holds team members accountable for underperformance. Leads by example and promotes PTx’s core Values: Learn, Prepare, Innovate, Collaborate, Lead to continually improve the Quality Culture at PTx.
• Meets consistently with all Direct Reports and as a team to ensure 2-way updates, conversations, and alignment on goals and priorities are clear and reinforced regularly.
• Through active leadership and coaching, while embracing PTx’s Values and Behaviors, holds Team accountable for compliance to all safety and quality regulations, ensures all team members directly or indirectly support cGMP activities, and have the necessary education, knowledge, and skills to perform their job in accordance with applicable procedures and regulations.
• Pro-actively creates opportunities to develop their Team, including ensuring career paths have been developed for Partners (as needed), and enhances the Team through cross-training others, identifying competency gaps, etc. 

KNOWLEDGE, SKILLS, ABILITIES

Required:

• Possesses subject matter expertise on the requirements of an FDA regulated biopharmaceutical manufacturing facility. Capable of providing expert analysis and interpretation of applicable standards, policies and guidance’s issued by relevant regulatory authorities that may impact the Company.
• SME of maintenance and oversight of facilities management
• Engineering Systems & Facilities Management – In-depth knowledge of site utilities (HVAC, boilers, chillers, cleanroom systems, purified water/clean steam systems), building management systems (BMS/BAS), and maintenance best practices.
• GMP and Regulatory Compliance – Comprehensive knowledge of FDA regulatory requirements impacting facilities and engineering within a GMP environment.
• Capital Project Management – Knowledge of capital planning, budgeting, and execution for facility expansions, upgrades, and reliability improvements.
• Asset Life Cycle Management – Knowledge of equipment qualification (IQ/OQ/PQ), maintenance strategies (preventive/predictive), and reliability engineering.
• EHS&S Standards – Knowledge of environmental, health, safety and security regulations affecting company operations.
• Financial Acumen – Understanding of cost control, budgeting, forecasting, and vendor contract management for site services and capital projects.
• Lean/Continuous Improvement – Knowledge of Lean, Six Sigma, or similar methodologies to drive operational excellence in engineering and facilities management
• Ability to align Site engineering strategy with overall business objectives, including long-range capacity planning.
• Skilled at managing external service providers, negotiating contracts, and monitoring KPIs. In depth knowledge of emergency response, disaster recovery and business continuity planning.
• Skilled at building trust and collaboration by delivering exceptional service while balancing the needs of the individual with the greater good.
• Skilled at managing multiple projects and resources simultaneously.
• Resourceful with proven ability to lead, manage and leverage an extensive internal network of stakeholders, team members, and external resources to plan and resolve issues. Strong, collaborative relationship management and interpersonal skills required to quickly gain confidence of stakeholders and team members.
• Strong critical thinking, analytical, and problem-solving skills with the proven ability to formulate strategic solutions to propel the organization forward.
• Possesses strong organizational and prioritization skills to maintain a high level of productivity, innovation, and priority-setting in order to complete assignments on-time and on-budget; experience with the principals of operational excellence. Demonstrated ability to delegate successfully.
• Excellent soft skills including a bias towards action, the ability and willingness to give and receive constructive feedback, is comfortable working within a diverse team and across multiple functions, exhibits a consistently constructive attitude, and is adaptable and at ease with handling unexpected changes and challenges.
• Strong written and oral English communication skills are required for this highly collaborative role. Proven ability to make clear, effective, and persuasive presentations to audiences at various levels of expertise required. Skilled at leading effective meetings.
• Solid software skills including Word, Excel, PowerPoint, Outlook; ability and willingness to quickly adopt other job-specific applications will be necessary.

Preferred:

• Formal project management training
• Experienced with workforce planning and operational budgeting.
• Software application experience

PEOPLE LEADERSHIP QUALIFICATIONS

Required:

• Demonstrated commitment to fostering the professional growth and development of others.
• Strong leadership skills included a demonstrated ability to drive accountability and build a culture of trust, compliance, efficiency, and continuous improvement.
• Proven ability to enhance engagement by driving an environment within which individuals can excel and continuously improve.
• Skilled at active listening, conflict resolution, and team building.
• Experience working collaboratively with HR/People & Culture functions to recruit, hire, grow, and retain talent. Proficiency in standard recruiting and hiring protocols; recent practical experience with the hiring processes as both a hiring manager and interviewer.
• Experienced at managing and developing the performance of direct reports by setting clear “SMART” goals, providing timely performance feedback, recognizing, and rewarding high achievers, and holding staff accountable for underperformance

EXPERIENCE & EDUCATION

Required:

• High School Diploma or GED.
• 15+ years progressively responsible experience in facilities and/or site engineering or related role within the Life Science, Biotechnology or Pharmaceutical industry (Bachelor’s degree or equivalent in related field may substitute for 2 years of professional experience.)
• 10+ years in People Leadership roles leading teams in a regulated environment. People Leadership qualification includes experience in recruiting, making hiring decisions, setting SMART Goals, growing and rewarding high performers, and addressing performance concerns.

Preferred:

• Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Chemical Engineering, or Biomechanical Engineering.
• Experience leading in a cGMP regulated environment
• Experience with CMMS, preventative and predictive Maintenance
• Professional Certifications such as PE, PMP, CFM, Six Sigma
• Experience working with FDA inspections/audits or other regulatory inspections

PTx is committed to the principles of competitive and pay equity for all of our Partners. The current pay range for this position is $184,000 - $222,300: Offers are made within the base pay range applicable at the time. Your salary will vary depending on several factors including your qualifications and experience.

In addition to medical, dental, vision, FSA/DCA, HRA, disability, and life insurance coverage, all full-time, regular Partners enjoy a casual, and Hybrid or Remote workplace program for many roles.  We offer a terrific compensation/benefits/perks package which includes pre-IPO options, annual cash bonuses, 401k matching, free parking or Seattle-area ORCA pass, tuition assistance, plus rewards for achievement and contribution. To support a healthy work-life balance we also provide a gym subsidy, wellness participation programs, and a generous vacation, sick, and holiday paid time off program in addition to a paid shutdown between the Christmas and New Year’s holidays.  

Partner Therapeutics is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex, age, national origin, veteran status, marital status, sexual orientation, gender identity, disability or any other category prohibited by local, state, or federal law. This policy applies to all aspects of employment, including recruitment, placement, promotion, transfer, demotion, compensation, benefits, social and recreational activities, and termination.