Manufacturing Technician I/II/III - MA (1st Shift)
Genezen
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Benefits offered by this job
Job summary
Genezen is seeking a manufacturing associate to perform routine and non-routine production operations in cell culture, purification, and related areas. The role is based in Lexington, MA and reports to the MFG Supervisor.
Responsibilities include shift handoffs, document control, and equipment maintenance in a cGMP environment, with adherence to GDP and regulatory expectations. Willingness to work holidays and overtime as needed.
Qualifications
- High School Diploma required; 2-4 years cGMP industry experience preferred.
- Associate’s or Bachelor's degree in Life Sciences/Engineering is desired.
- Must be able to adhere to internal and regulatory policies and procedures.
- Strong writing and oral communication skills and attention to detail.
Responsibilities
- Attend daily meetings and share shift information.
- Maintain orderly, safe, and compliant process areas with supplies.
- Perform routine and non-routine production operations per MFG schedule.
- Document operations in BPR, SLR, logbooks and forms per GDP.
- Perform page reviews and support equipment cleaning, standardization, and changes.
Skills
Education
Job description
Manypeople have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.
Manufacturing performs all required process steps and in process controls, in close collaboration with MSAT, QC, QA, Engineering and Validation.
With general supervision the individual will perform routine and non-routine manufacturing operations, including but not limited to work functions in Cell Culture, Purification, Solution & Equipment Prep areas. Operates production equipment according to SOPs for the production of clinical and/or commercial products.
This position is located in Lexington, MA and reports to the MFG Supervisor.
- Attend daily meetings including shift hand off and ensure relevant information is shared between shifts
- Perform weekly/monthly walkthroughs and ensure areas are maintained in a safe and compliant state
- Maintaining orderliness of process area and stocking production area with supplies from collaboration with Supply Chain
- Demonstrating general knowledge of aseptic techniques
- Perform troubleshooting activities according to SOPs
- Execute routine and non-routine production operations according to MFG schedule, including off shift production activities when needed
- Document operations according to GDP principles in Batch Production Record (BPR), Solution records (SLR), Logbooks and Forms
- Perform page reviews in BPRs, SLRs, Logbooks, and Forms
- Carry out work in a safe manner, notifying management of safety issues and risks
- Maintain up-to-date training folder for applicable processes
- Required to work holidays and overtime as needed to support the manufacturing process
This individual will manage equipment and support facility related projects by:
- Perform scheduled cleaning of equipment
- Perform standardization of equipment
- Support product change over activities
- Support equipment and process qualifications if needed
- Escalate work requests to Senior or Lead Technicians for submission in work request management system
Staff Technical Training and Development:
- Propose continuous improvement, process, and human performance document revisions
- Escalate and contributes to process improvement and manufacturing Continuous Improvement items
- Develop and maintain personal development plan
- Provide annual performance self-assessment
- Normally requires a high school diploma and 2-4 years related cGMP industry experience or an Associate’s Degree in Life Sciences/Engineering field with 1 year of cGMP
- Manufacturing experience or Bachelor’s degree in life Sciences/Engineering field
- Preferably working experience in a comparable position (similar type of work, similar group dynamics), preferentially in an industrial organization
- Ability to adhere to company internal and regulatory (EMA, FDA) policies, processes and procedures
- Hands-on experience in writing and reviewing documentation
- Experience in (bio)-manufacturing unit operations (USP and/or DSP)
- Good writing and oral communication skills
- Applies experience and skills to complete assigned work within own area of expertise
- Works within standard operating procedures and/or scientific methods
- Comfortably able to lift up to 40lbs
- Adaptability required as work schedule may change based on business needs
- Criminal background check required
- Other duties as assigned
- EDUCATION / CERTIFICATIONS / LICENSES
Essential/Desired - High School Diploma
Essential - Associate’s Degree in Life Sciences/Engineering
Desired - Bachelor’s Degree in Life Sciences/Engineering
Desired - ON-THE-JOB EXPERIENCE
- 2-4 years related industry experience
Desired - SKILLS / ABILITIES
- Has process-oriented way of thinking and working
Essential - Is detail oriented
Essential - Is self-organized
Essential - Is able to communicate in professional way on diverse levels and channels
Essential - Is capable of taking initiative when necessary
Essential - Has a flexible attitude in a challenging environment
Essential - Is intrinsically motivated
Essential
The hourly compensation range for this position is $28-$40/hour.
While performing the duties of this job, the employee is required to meet the following physical demands:
- Regularly sit for long periods of time
- Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; use hands to finger, handle, or feel; reach with hands and arms
- Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl
- Frequently lift and/or move up to 20 pounds
- Rarely lift and/or move up to 40 pounds
- Frequently utilize close vision and the ability to adjust focus
- Frequently required to communicate by talking, hearing, using telephone and e-mail
We are committed toscientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.
We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.
We are committed to overcoming challenges, learning from failures, and persistently striving for success.
We are dedicated to delivering quality results and upholding ethical principals.
We are committed to being a proactive, collaborative, creative and open-minded partner.
- Paid vacation days, amount based on tenure
- Paid sick time
- 10 observed holidays + 2 floating holiday + 1 volunteer day
- 401(k) plan with company match up to 6% of salary
- Share Appreciation Rights
- Choice of several healthcare plans
- FSA and HSA programs
- Dental & vision care
- Employer-paid basic term life/personal accident insurance
- Voluntary disability, universal life/personal accident insurance
- Accidental Death & Dismemberment (AD&D) Insurance
- Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
- This position requires a criminal background check.
- Genezen is an Equal Opportunity Employer.
- Genezen participates in EVerify.
- Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.
Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.
Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world’s largest children’s museum--to name just a few reasons why this area is a great place to live.
Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.
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