Location: all cities,NH, USA
Job Title: Manufacturing Associate Level 1
Location: Portsmouth, NH
At Viltis, we are dedicated to providing consulting services to the biotech and pharmaceutical industries. We believe that our greatest resource is talented people working together to help improve healthcare solutions. We empower our employees to own their careers, and their contributions, big and small, genuinely make a difference.
Shift Schedule:
- 7am-7pm on a rotational schedule every other week:
- Week 1: MON/TUE/FRI/SAT/SUN
- Week 2: WED/THUR
- Initial 2-week training period on day shift Monday-Friday for new hires
- Shift differentials are included for weekends worked
Position Summary:
The Manufacturing Associate Level 1 will support the production of therapeutic proteins under current Good Manufacturing Practices (cGMP) conditions. This role involves executing process recipes, following Standard Operating Procedures (SOPs), monitoring equipment, and performing laboratory tasks such as pH and conductivity testing, product sampling, and routine sanitization. Level 1 associates work under supervision while demonstrating a strong understanding of cGMP compliance and aseptic techniques.
Key Responsibilities:
- Set up and operate equipment, monitor production processes (e.g., clean-in-place (CIP) and steam-in-place (SIP)), and report production in written and electronic formats in accordance with Good Documentation Practices (GDPs).
- Troubleshoot equipment issues and review documentation as necessary.
- Attain qualification for assigned tasks and maintain an individual training plan.
- Perform laboratory tasks such as monitoring pH, conductivity, and product sampling.
- Support facility cleanliness by performing routine sanitization and participating in 6S programs.
- Assist with material movement and transfer of materials and chemicals within production areas.
- Participate in administrative tasks, including shift exchanges, meetings, and project involvement.
- Support data integrity by following policies, guidelines, and procedures and identifying issues to management.
Key Requirements:
- High School Diploma or equivalent minimum; AS/BS in a science-related discipline preferred.
- Experience in cleanroom or sterile environments is a plus.
- Experience with mammalian cell culture is a plus.
- Prior experience with gowning or PPE procedures in a sterile setting preferred.
- Experience in manufacturing, particularly in a cGMP setting, or as a Level 1 Associate in the biopharma industry.
- Ability to follow detailed documentation procedures in a regulated industry.
- Critical thinking, logic, and decision-making skills.
- Strong written and verbal communication skills.
- Flexibility to adapt to changing priorities and openness to feedback.
If you are looking to advance your career in biopharma manufacturing, Viltis offers an environment where your ideas can make a real impact.
NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law, including disability/veteran status. This position may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time at the Company's facilities.