Manufacturing Associate III
We are currently seeking an experienced Manufacturing Associate III to join our team in our Milford, MA location.
Who We Are:
Rentschler Biopharma - makes an essential contribution to the worldwide availability of biopharmaceuticals. We are a strong and growing family-owned company employing approximately 850 employees. Last year Rentschler doubles its manufacturing capacity to address growing demand for biopharmaceuticals. To address this expansion, we must enlarge our team; our strategy has been to grow outside of Laupheim Germany.
As of the beginning of 2019 we acquired a manufacturing site in Milford, MA. What unites us at Rentschler, is the passion for what we do. Every member of our team, with the knowledge and skills, is actively committed to the success of our projects. You can become a part of our team! We offer you an exciting work environment with excellent career development opportunities. The benefits are excellent as well! We welcome you to review us more closely and look at our open opportunities. To learn more about us, please visit us at www.rentschler-biopharma.com/
About the Role:
This position is focused on biologics manufacturing, which includes processing in upstream (cell culture) and downstream (purification). Operators are expected to perform these processes while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which apply.
What you’ll do:
Core duties and responsibilities include the following. Other duties may be assigned
- Perform operations of the following (may be applicable to commercial scale product, development studies, clinical scale or validation activities).
- Strong knowledge and understanding of manufacturing process and equipment to perform various production steps.
- Ability to train employees.
- Subject matter expert operating production equipment, as needed.
- Monitor and record batch parameters, including computer data entry.
- Complete relevant paperwork following GDP/GMP guidelines.
- Perform mathematical calculations related to production processes.
- Initiate new documents for procedures; may make minor revisions to existing documents.
- Work with support team on all necessary event investigations and inventory system cycle counts and discrepancies.
- Troubleshoot process problems and respond to alarms.
- Provide information for unplanned events, including entering data into event management software.
- Oversee training of new employees, track training requirements for team members ensuring appropriate training is completed prior to process execution.
- Order, receive and distribute supplies into production area as needed.
- Convey information to external stake holders (auditors, global colleagues, etc.).
- Oversee support for groups that support manufacturing (such as external cleaners, etc.).
- Lead Continuous Improvement Teams (such as 5S, Gemba, OMT, etc.).
- Demonstrate procedures as a part of training sessions for other team members; may schedule department or process activities which could involve coworkers.
- Lead team meetings and facilitate multidepartment discussions.
- Provide knowledge in areas of training process improvements.
- Such additional responsibilities as the Company may also assign.
Our Perfect Candidate
Education and Experience:
- High school diploma with 3-6 years of related experience required
- Associate’s Degree in Life Sciences/Engineering field
- Biotech Certification highly preferred
- Bachelor’s Degree with 1-4 years of related experience
- Demonstrated knowledge of CGMP manufacturing
- Knowledge of laboratory and pharmaceutical production equipment
Required Abilities and Skills:
- Strong interpersonal, verbal, and written communication skills
- Able to read and follow detailed written instructions and have good verbal/written communication skills.
- Able to write legibly and grammatically correct entries on records. Must be able to author technical procedures and create forms.
- Familiar with standard troubleshooting approaches (problem statement, root cause analysis, corrections, etc.)
- Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience
- Must be able to work independently without direct supervision
- Expertise in analysis, critical decision making, and process improvement
- Good interpersonal skills and can work effectively and efficiently in a team environment
- Ability to meet schedule required; this position may include shift, weekend, holiday work and overtime at times, as dictated by the 365-day per year production schedule
- Ability to work in a clean room environment and comply with hygiene standards and use of special garments
- Additionally, personal protective equipment must be worn due to safety requirements
- Proficiency in Microsoft Office Applications including Excel, PowerPoint, and Word
- Competitive salary will commensurate with experience and education
- Comprehensive benefits package available: You will be eligible to participate in Company-sponsored benefits, which currently include healthcare, vision, dental, 401(k), life insurance, short term disability, long term disability, flexible spending account, and PTO, great working environment and engaged employees!
Please submit your cover letter, and resume
via the ‘Apply Now’ button!
We are an Equal Opportunity Employer!
Keywords: Business Process Analyst, Manufacturing Coordinator, Manufacturing Technology Analyst, Product Manager
Advanced Manufacturing Engineer, Advanced Manufacturing, Facility Engineer, Manufacturing Engineer, Manufacturing Engineering, Plant Engineer, Process Engineer, Process Improvement Engineer, Biologics Manufacturing