The Manufacturing Associate will be responsible for the performance of all critical manufacturing steps in support of all GMP operations in the Support Operations group.
ESSENTIAL FUNCTIONS
The Manufacturing Associate will execute the preparation of media/ buffer solutions utilizing disposable mixing technology, raw material sampling and submission, and preparation of process equipment using a washer and autoclave.
Provide hands-on support in the operation of GMP manufacturing equipment to support commercial manufacturing.
Review/revision of SOPs and Master Batch Record (MBR) instructions to improve operational accuracy and efficiency.
Execute SAP transactions in a commercial environment.
Support in troubleshooting product and equipment issues and deviations. Assist in providing timely reporting, investigation, and resolution of manufacturing deviations, change control, and corrective/preventive actions.
Interact cross-functionally with Downstream Ops., Upstream Operations, Facilities, R&D, Quality Assurance, Quality Control, Validation, and other internal and external functions to support successful manufacturing campaigns.
Ensure adherence of operations to cGMP, ICH, EMA and JP Guidelines and industry safety standards and OSHA guidelines.
EQUIPMENT PREPARATION:
Responsible for completing assigned tasks which include cleaning, sterilizing, and prepping glassware and parts used in the manufacturing environment.
Work with senior technicians and leads to prioritize tasks and assignments and make recommendations to maximize efficiency and productivity based on shift needs.
Support the shift by completing required training in all areas of Equipment Preparation within the specified training curriculum.
Increase the efficiency and effectiveness of the shift towards meeting department goals.
STOCK SOLUTIONS:
Responsible for completing assigned tasks, which include media preparation, filtration, sterile pipetting, CIP, SIP, and rigorous inventory management while working with an ERP system and an MES system.
Work with senior technicians and leads to prioritize tasks and assignments and make recommendations to maximize efficiency and productivity based on shift needs.
Support the shift by completing required training in all areas of Stock Solutions within the specified training curriculum.
Increase the efficiency and effectiveness of the shift towards meeting department goals.
PREWEIGH:
Responsible for completing assigned tasks, which include sub-aliquoting powders and liquids into smaller containers while using an ERP system and MES system, obtain materials for manufacturing operations, and follow a production schedule.
Rigorous inventory management
Work with senior technicians and leads to prioritize tasks and assignments and make recommendations to maximize efficiency and productivity based on shift needs.
Support the shift by completing required training in all areas of Preweigh within the specified training curriculum.
Increase the efficiency and effectiveness of the shift towards meeting department goals.
REQUIREMENTS
Minimum of a High School (HS) degree with some college-level course work in biological science, physical sciences or at least 2 years of relevant experience; BA/BS in Life/Physical Sciences or equivalent preferred.
Minimum of 1-3 years' experience in buffer/media support operations at a pharmaceutical or biotechnology company
cGMP Technician must have a high standard for safety and the highest level of attention to detail
Gowning in the form of hospital scrubs, coveralls, gloves, and steel toe boots.
Knowledge of international (21CFR, EMEA, and JP) cGMP regulations.
Knowledge of SAP Process systems as used in a regulated manufacturing environment (not IT SAP role)
Must possess good problem solving, mechanical aptitude, interpersonal communication and team skills.
Must be a self-starter with strong focus on quality, details and results. Possess effective time management and organizational skills. Must be able to be flexible in work assignments, work weekends, off shifts and overtime as required. Possess proficiency in business applications including inventory control systems.
This position requires working within a cGMP facility and the technician will be required to wear a plant dedicated uniform (polyester) and a full coverall (Gowning -high-density polyethylene fibers) over the plant uniform. No makeup or nail polish is allowed when gowned. Technician must be able to use hand sanitizer (alcohol), hair/beard covers, and be comfortable with working with and around powered industrial trucks (motorized pallet jacks). Technician must be able to lift up to 25 lbs.
Working within a cleanroom environment requires:
No makeup or jewelry can be worn when working in the cleanroom environment.
No jewelry or makeup allowed in the production area including earrings and fake nails, eyelashes
Knowledgeable in weigh, dispense, and sampling procedures for controlled raw materials
Knowledgeable in the operation of all area specific production equipment such as washers, autoclaves, and disposable mixing technology for media and buffer solutions.
Ability to identify, investigate, and resolve basic process and equipment problems.
Flexibility to multi-task and adjust to varying priorities to meet timelines and schedule changes in Support Operations.
Self-starter with a strong focus on detail, safety, quality and results.
Strong written and verbal communication skills.
Candidates must be able to work 12 hour Day/NIGHT SWING shift including weekends. Four shifts****
D1 (Su - Tu, alt Wed, 0700 - 2000)
N1 (Su - Tu, alt Sat, 1900 - 0800) - GRAVE
D2 (Th - Sa, alt Wed, 0700 - 2000)
N2 (W - Fr, alt Sat, 1900 - 0800) - GRAVE
Opportunity is Calling, Apply Now!
What's In It For You?
We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you.
Medical, Dental & Vision Benefits
401K Retirement Saving Plan
Life & Disability Insurance
Direct Deposit & weekly ePayroll
Employee Discount Programs
Referral Bonus Programs
Yoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK. Find out more here!
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.
