Project Manager Senior

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Job description

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.

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