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Sr. Project Manager
COMPANY DESCRIPTION:
A career here is life-enhancing.
At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video here.
Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner.
Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation.
At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.
For more information, visit www.Synergbiopharma.com
POSITION OVERVIEW:
We are seeking a highly experienced Sr. Project Manager to lead the planning, implementation, and execution of an integrated Verification and Commissioning & Qualification (C&Q) Program for large-scale GMP-regulated capital projects.
This role will be responsible for driving a verification-based approach that applies the principles of the right people, performing the right activities, at the right time, integrating commissioning and qualification activities throughout the entire project lifecycle. Rather than treating commissioning and qualification as separate sequential efforts, this role ensures an efficient and compliant C&Q strategy beginning in the design phase and continuing through construction, startup, verification, system turnover, and operational handover.
WORK LOCATION:
Travel to client sites may be required up to 100%, depending on project needs and client expectations.
KEY RESPONSIBILITIES:
This list is not exhaustive and may be supplemented or adjusted as needed.
- Lead the development and execution of an integrated Verification and C&Q Program across the full project lifecycle, from design through operational handover.
- Establish and implement project-specific verification strategies aligned with ASTM E2500 principles and industry best practices.
- Manage overall C&Q scope, budget, schedule, resource planning, and project risks.
- Serve as the primary point of contact for all C&Q-related matters with project leadership and key stakeholders.
- Develop detailed C&Q execution plans, staffing strategies, milestone schedules, and performance metrics.
- Ensure C&Q activities are integrated with engineering, construction, automation, validation, quality, and operational readiness plans.
- Lead, mentor, and develop multidisciplinary C&Q teams supporting project execution.
- Manage day-to-day team activities, task assignments, priorities, and performance.
- Facilitate daily, weekly, and monthly project meetings to track progress and resolve issues.
- Provide technical guidance and oversight to ensure consistent application of verification methodologies and C&Q best practices.
- Train project teams, contractors, and service providers on verification-based delivery methodologies and project-specific C&Q requirements.
- Oversee implementation of the project verification strategy, ensuring verification activities are executed by the appropriate functional teams throughout the project lifecycle.
- Direct development, review, approval, and execution of verification plans, test cases, commissioning protocols, and qualification documentation.
- Ensure requirements traceability from design through testing and final system acceptance.
- Support risk-based qualification approaches and critical aspect verification in accordance with ASTM E2500 principles.
- Ensure timely completion of turnover packages and system release activities.
- Collaborate closely with Engineering, Construction, Automation, Quality Assurance, Validation, Manufacturing, Facilities, and Project Controls teams.
- Drive alignment between project objectives, design intent, compliance requirements, and operational expectations.
- Facilitate resolution of technical, compliance, and execution challenges impacting C&Q deliverables.
- Influence project decisions and priorities to support successful delivery of verification and qualification objectives.
- Monitor and report project progress, resource utilization, budget performance, and key C&Q metrics.
- Identify and mitigate schedule, quality, compliance, and execution risks.
- Escalate critical issues impacting project delivery and drive timely resolution.
- Provide regular status updates and executive-level communications to project leadership and stakeholders.
- Promote a strong safety culture and ensure compliance with all site and project safety requirements.
- Ensure implementation of safe work practices, permitting requirements, and field execution procedures.
- Maintain compliance with GMP regulations, quality systems, and applicable industry standards throughout project execution.
- Support audits, inspections, and regulatory interactions as required.
QUALIFICATIONS AND REQUIREMENTS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education
- Bachelor's Degree in Engineering, Life Sciences, or a related technical discipline.
- Advanced degree, PMP certification, or equivalent professional certification preferred.
Technical Experience
- 10–15+ years of experience supporting GMP-regulated pharmaceutical, biotechnology, cell and gene therapy, or medical device projects.
- Demonstrated experience leading Commissioning, Qualification, Verification, or Validation programs on large capital projects.
- Experience delivering at least one major greenfield or brownfield GMP facility from early design through startup, qualification, turnover, and project closeout.
- Strong knowledge and application of ASTM E2500 verification methodology and risk-based qualification approaches.
- Experience managing FAT, SAT, commissioning, qualification, verification testing, and system turnover activities.
- Working knowledge of facility, utility, process, automation, and manufacturing systems commonly deployed within GMP environments.
- Experience managing budgets, resource plans, schedules, and contract service providers.
- Familiarity with GMP documentation practices, quality systems, change controls, deviations, CAPAs, and validation lifecycle requirements.
- Experience with electronic validation systems and digital quality platforms, including Kneat, ValGenesis, or similar platforms, is preferred.
Knowledge, Skills, and Abilities
- Strong understanding of GMP regulations, commissioning, qualification, validation, and verification practices.
- Deep knowledge of ASTM E2500 and lifecycle-based validation methodologies.
- Demonstrated leadership experience managing large, cross-functional project teams.
- Excellent organizational, planning, and project management skills.
- Strong communication skills with the ability to engage effectively with technical and non-technical stakeholders.
- Proven ability to influence decision-making and drive alignment across multiple functional groups.
- Strong analytical, problem-solving, and risk-management capabilities.
- Ability to manage multiple priorities in fast-paced project environments.
- Commitment to quality, compliance, safety, and continuous improvement.
ESSENTIAL FUNCTIONS:
Physical Demands:
The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.
TOTAL REWARDS PROGRAM:
We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.
LEGAL STATEMENT:
Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employer. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.
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