Actalent Woodinville , WA 98072
Posted 2 months ago
Description:
Direct oversight of manufacturing floor operations
Responsible for the daily organization of workflow; delegate responsibilities for shift operations as needed.
Ensure completion of scheduled daily tasks.
Responsible for the review and approval of executed manufacturing MBRs
Floor review of executed batch records and logbooks.
Monitoring of staff during operations as described in standard operating procedures and batch records.
Ensure staff compliance with all company/regulatory quality systems, safety procedures, and SOPs.
Support internal, client, and regulatory audits and inspections
Review and ensure errors during manufacturing operations are corrected.
Establish priorities, set clear expectations, and demonstrate high standards of work practices.
Train, coach, and mentor manufacturing team on manufacturing functions.
Promote a safe work environment.
Personnel development and performance review
Generation of Manufacturing performance metrics
Investigation, documentation, and completion of manufacturing non-conformances
Generation, completion, and effectiveness verifications of Manufacturing corrective and
New employee onboarding
Preparation of batch manufacturing records and SOPs as required.
Ensure compliance with all safety requirements and procedures.
Execution of manufacturing processes per approved Manufacturing Batch Records
Participation in cross-functional teams
Sterile solution and media preparation
In-process analytical testing
Support a culture of continuous improvement throughout manufacturing.
Organization of Manufacturing areas, maintaining proper organization and cleanliness
Other projects as assigned.
Qualifications:
Highly organized with an attention to detail
5+ years of cGMP related manufacturing experience in the biopharmaceutical industry, including 2+ years leading a team/group
Proficiency in one or more of the following: chromatography, fermentation, tangential flow filtration, conjugation, homogenization
Broad experience with manufacturing process equipment in a GMP environment
Proficient in Microsoft Office applications
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Actalent