Vitalent
Pinnaql
is a trusted consulting partner to regulated life sciences companies, providing deep technical, validation, and quality expertise across every stage of the product lifecycle. We partner with pharmaceutical, biotech, and medical device organizations to navigate complexity, accelerate project timelines, and maintain a strong state of compliance and audit readiness.
Validation and Engineering Group , a Pinnaql company, is seeking an
Operational Readiness Project Manager
with expertise in biopharmaceutical manufacturing operations to support a biologics manufacturing facility. This role will focus on ensuring a smooth transition of operational and quality processes supporting a large-scale MES migration and modernization project.
Position Overview The
Operational Readiness Project Manager
will lead and coordinate all readiness activities for the site, ensuring that manufacturing, quality, and business process impacts are fully assessed, planned, and executed to support the MES (Manufacturing Execution System) migration. The successful candidate will possess strong organizational and leadership skills, thrive in fast-paced environments, and have a proven ability to manage multiple priorities in a highly regulated pharmaceutical setting.
Key Responsibilities
Lead cross-functional business process mapping sessions to identify and document readiness requirements Develop and manage detailed project schedules, ensuring alignment with program milestones Drive tracking and adherence to plans for documentation updates and operational procedures Collaborate within matrixed teams to assess Electronic Batch Record (EBR) impacts across functions Serve as the primary liaison between operations, quality, and project teams to drive decision-making and accountability Ensure project deliverables meet GxP compliance and quality standards Support change management and communication activities to facilitate a seamless transition Frequent interaction with project teams, contractors, and operations staff in a collaborative environment
Qualifications and Experience
6+ years of project management experience within the pharmaceutical or biotech industry Proven success leading or supporting operational readiness components of large-scale initiatives Strong understanding of operational and quality assurance processes within drug substance manufacturing Exposure to MES (Syncade) and Electronic Batch Records (EBR) highly preferred Familiarity with PMBOK/PMI project management principles Proficiency with MS Project, Smartsheet, and other project management tools Excellent communication and interpersonal skills; ability to lead and influence within matrixed teams Organized, proactive, and detail-oriented, with strong ownership of deliverables
At Pinnaql, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job; it's your opportunity to make a meaningful difference. You'll help shape the future of healthcare and technology, working alongside a purpose-driven team that's as ambitious as it is supportive. Excited to build something meaningful together? We look forward to hearing from you!
Pinnaql is an equal opportunity employer.
All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.
#LI-LN1
#LI-ONSITE
is a trusted consulting partner to regulated life sciences companies, providing deep technical, validation, and quality expertise across every stage of the product lifecycle. We partner with pharmaceutical, biotech, and medical device organizations to navigate complexity, accelerate project timelines, and maintain a strong state of compliance and audit readiness.
Validation and Engineering Group , a Pinnaql company, is seeking an
Operational Readiness Project Manager
with expertise in biopharmaceutical manufacturing operations to support a biologics manufacturing facility. This role will focus on ensuring a smooth transition of operational and quality processes supporting a large-scale MES migration and modernization project.
Position Overview The
Operational Readiness Project Manager
will lead and coordinate all readiness activities for the site, ensuring that manufacturing, quality, and business process impacts are fully assessed, planned, and executed to support the MES (Manufacturing Execution System) migration. The successful candidate will possess strong organizational and leadership skills, thrive in fast-paced environments, and have a proven ability to manage multiple priorities in a highly regulated pharmaceutical setting.
Key Responsibilities
Lead cross-functional business process mapping sessions to identify and document readiness requirements Develop and manage detailed project schedules, ensuring alignment with program milestones Drive tracking and adherence to plans for documentation updates and operational procedures Collaborate within matrixed teams to assess Electronic Batch Record (EBR) impacts across functions Serve as the primary liaison between operations, quality, and project teams to drive decision-making and accountability Ensure project deliverables meet GxP compliance and quality standards Support change management and communication activities to facilitate a seamless transition Frequent interaction with project teams, contractors, and operations staff in a collaborative environment
Qualifications and Experience
6+ years of project management experience within the pharmaceutical or biotech industry Proven success leading or supporting operational readiness components of large-scale initiatives Strong understanding of operational and quality assurance processes within drug substance manufacturing Exposure to MES (Syncade) and Electronic Batch Records (EBR) highly preferred Familiarity with PMBOK/PMI project management principles Proficiency with MS Project, Smartsheet, and other project management tools Excellent communication and interpersonal skills; ability to lead and influence within matrixed teams Organized, proactive, and detail-oriented, with strong ownership of deliverables
At Pinnaql, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job; it's your opportunity to make a meaningful difference. You'll help shape the future of healthcare and technology, working alongside a purpose-driven team that's as ambitious as it is supportive. Excited to build something meaningful together? We look forward to hearing from you!
Pinnaql is an equal opportunity employer.
All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.
#LI-LN1
#LI-ONSITE