ApTask
Project Manager Senior
ApTask, Thousand Oaks, California, United States, 91362
About Client:
The client is one of the world's largest independent biotechnology companies, focusing on the discovery, development, and manufacturing of innovative human therapeutics. The company's areas of expertise include oncology, hematology, cardiovascular disease, inflammation, bone health, and neuroscience.
It has developed a wide range of biologic medicines, including biotechnology drugs, therapeutic antibodies, and other innovative therapies. The company collaborates with academic institutions, biotechnology partners, and other organizations to advance its research efforts.
Rate Range:
Job Description:
Looking for a Senior level PM who will support manufacturing plant and engineering group, This person needs to have process/utility Engineering technical experience and not only be quality background driven. This engineering position supports projects that associated with cGMP equipment and facilities at Client Thousand Oaks (ATO). The engineer will lead project engineering and construction activities in alignment with the engineering workstreams (i.e. Trades during construction, project management budget, schedules, safety, and Client's Commissioning and Qualification Process (CQP) to ensure that new GMP equipment is installed and maintained in a validated state, equipment & facilities design and compliance, project management, etc.). The staff works in partnership with the maintenance, Project Management, Engineering Technical Lead, and manufacturing to develop and oversee the operation and reliability of equipment. The position must work closely with Environmental Health Safety Services (EHSS) and Quality Assurance (QA) for compliance. The position will support the projects in defining strategies for quality systems verification and will work with the process development / validation team to develop and document appropriate practices for characterization. Preferred Qualifications / Skills / Experience:
Bachelor's degree in engineering or another science-related field 2+ years of relevant work experience with 1+ years' experience in operations/manufacturing environment Direct experience with regulated environments (FDA, OSHA, EPA, etc.) Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, clean utilities, facilities, instruments and equipment Experience implementing risk-based verification on major GMP process equipment / automation projects, including validation protocol development and execution Experience with combination product / medical device quality systems verification Process equipment knowledge - cell culture, fermentation, purification, filling, and packaging Process automation knowledge - understanding of automation infrastructure, current technologies, and automation project execution / verification. Knowledge of Delta V, Rockwell, and Plant Information Systems is a plus Demonstrated strong communication and technical writing skills Strengths in facilitation and collaboration / networking Experience in developing SOPs and delivering training Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making Good record of applying process improvement methodologies to mature and improve business processes (e.g. PDCA, LEAN, Six Sigma, and fundamental understanding of statistics, etc.) Demonstrated skills in the following areas:
Problem solving and applied engineering. Basic technical report writing. Verbal communication;
About ApTask: ApTask is a leading global provider of workforce solutions and talent acquisition services, dedicated to shaping the future of work. As an African American-owned and Veteran-certified company, ApTask offers a comprehensive suite of services, including staffing and recruitment solutions, managed services, IT consulting, and project management. With a focus on excellence, collaboration, and innovation, ApTask provides unparalleled opportunities for professional growth and development. As a member of the ApTask team, you will have the chance to connect businesses with top-tier professionals, optimize workforce performance, and drive success across diverse industries. Join us at ApTask and be part of our mission to empower organizations to thrive while fostering a diverse and inclusive work environment.
Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview.
Candidate Data Collection Disclaimer: At ApTask, we prioritize safeguarding your privacy. As part of our recruitment process, certain Personally Identifiable Information (PII) may be requested by our clients for verification and application purposes. Rest assured, we strictly adhere to confidentiality standards and comply with all relevant data protection laws. Please note that we only collect the necessary information as specified by each client and do not request sensitive details during the initial stages of recruitment.
If you have any concerns or queries about your personal information, please feel free to contact our compliance team at businessexcellence@aptask.com
Rate Range:
Job Description:
Looking for a Senior level PM who will support manufacturing plant and engineering group, This person needs to have process/utility Engineering technical experience and not only be quality background driven. This engineering position supports projects that associated with cGMP equipment and facilities at Client Thousand Oaks (ATO). The engineer will lead project engineering and construction activities in alignment with the engineering workstreams (i.e. Trades during construction, project management budget, schedules, safety, and Client's Commissioning and Qualification Process (CQP) to ensure that new GMP equipment is installed and maintained in a validated state, equipment & facilities design and compliance, project management, etc.). The staff works in partnership with the maintenance, Project Management, Engineering Technical Lead, and manufacturing to develop and oversee the operation and reliability of equipment. The position must work closely with Environmental Health Safety Services (EHSS) and Quality Assurance (QA) for compliance. The position will support the projects in defining strategies for quality systems verification and will work with the process development / validation team to develop and document appropriate practices for characterization. Preferred Qualifications / Skills / Experience:
Bachelor's degree in engineering or another science-related field 2+ years of relevant work experience with 1+ years' experience in operations/manufacturing environment Direct experience with regulated environments (FDA, OSHA, EPA, etc.) Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, clean utilities, facilities, instruments and equipment Experience implementing risk-based verification on major GMP process equipment / automation projects, including validation protocol development and execution Experience with combination product / medical device quality systems verification Process equipment knowledge - cell culture, fermentation, purification, filling, and packaging Process automation knowledge - understanding of automation infrastructure, current technologies, and automation project execution / verification. Knowledge of Delta V, Rockwell, and Plant Information Systems is a plus Demonstrated strong communication and technical writing skills Strengths in facilitation and collaboration / networking Experience in developing SOPs and delivering training Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making Good record of applying process improvement methodologies to mature and improve business processes (e.g. PDCA, LEAN, Six Sigma, and fundamental understanding of statistics, etc.) Demonstrated skills in the following areas:
Problem solving and applied engineering. Basic technical report writing. Verbal communication;
About ApTask: ApTask is a leading global provider of workforce solutions and talent acquisition services, dedicated to shaping the future of work. As an African American-owned and Veteran-certified company, ApTask offers a comprehensive suite of services, including staffing and recruitment solutions, managed services, IT consulting, and project management. With a focus on excellence, collaboration, and innovation, ApTask provides unparalleled opportunities for professional growth and development. As a member of the ApTask team, you will have the chance to connect businesses with top-tier professionals, optimize workforce performance, and drive success across diverse industries. Join us at ApTask and be part of our mission to empower organizations to thrive while fostering a diverse and inclusive work environment.
Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview.
Candidate Data Collection Disclaimer: At ApTask, we prioritize safeguarding your privacy. As part of our recruitment process, certain Personally Identifiable Information (PII) may be requested by our clients for verification and application purposes. Rest assured, we strictly adhere to confidentiality standards and comply with all relevant data protection laws. Please note that we only collect the necessary information as specified by each client and do not request sensitive details during the initial stages of recruitment.
If you have any concerns or queries about your personal information, please feel free to contact our compliance team at businessexcellence@aptask.com