Bioprocess Associate (2nd Shift) (Onsite, Devens, MA)

Stage 4 Solutions, Inc.; Harvard (MA); Sur place; USD 48 000 - 52 000; Plein temps

Avantages offerts par ce poste

Health benefits

401K

Résumé du poste

Stage 4 Solutions, Inc. is seeking a Bioprocess Associate for the 2nd shift at Devens, MA. This on-site role is 40 hours per week on a 3-month contract with a 5pm–5am rotation and a specific weekend schedule.

You will collaborate with bioprocess and quality teams, participate in inline sampling, and assist with SOP updates and equipment preparation in a cGMP environment.

Qualifications

• 0-3 years of proficiency with common computer tools (word processing, spreadsheets).
• Experience in manufacturing and cGMP environments; use of hand tools.
• Experience with process automation systems (DeltaV, Syncade Interactions, Pi Vision) and business systems (SAP, Infinity, Maximo).
• Attention to detail and personal accountability in work/study contexts.
• High school diploma required; a B.S. in science/engineering/biochemistry or related field is desirable but not required.

Responsabilités

• Work on routine manufacturing assignments per written procedures and recognize deviations.
• Adhere to GMPs and SOPs; maintain clean room environment to comply with regulatory requirements.
• Weigh and check raw materials; assemble, clean, and sterilize process equipment; monitor processes.
• Train for proficiency on primary production equipment (bioreactors, chromatography skids, media/buffer prep).
• Assist with revision/creation of process documents and maintain inventory levels.

Connaissances

Manufacturing experience

Attention to detail

Team collaboration

Formation

High school diploma

B.S. in science/engineering/biochemistry (desired)

Outils

DeltaV

Syncade Interactions

Pi Vision

SAP

Infinity

Maximo

Description du poste

Bioprocess Associate (2nd Shift) (Onsite, Devens, MA)

We are seeking a Bioprocess Associate for a global pharmaceutical client. You will work in teams and have continual interaction with members of teams as well as other bioprocess teams throughout the manufacturing process in order to exchange information regarding the batch(s) in process. In addition there will be frequent contact with members of the Quality department with regard to inline sampling and variance investigation.

This is a 40-hour per-week, 3-month contract (extensions possible), 100% onsite role at client s office in Devens, MA. Shift: 5pm- 5am

Shift rotation: 3 days on (Sat, Sun, Mon), 2 days off (Tues, Wed), 2 days on (Thurs, Fri), 3 days off (Sat to Mon).

This is a W2 role as a Stage 4 Solutions employee. Health benefits and 401K are offered.

Responsibilities

• Works on routine manufacturing assignments per written procedures, where ability to recognize deviation from accepted practice is required.

Adheres to Good Manufacturing Practices and standard operating procedures.

• Weighs and checks raw materials. Assembles, cleans, and sterilizes process equipment, monitors processes. Completes electronic work instructions and maintains clean room environment to comply with regulatory requirements.
• Trains for proficiency in the operation of primary production equipment within the assigned functional area (i.e. bioreactors, chromatography skids, media or buffer preparation equipment etc.)
• Assist with the revision and or creation of process documents, such as SOPs and electronic work instructions. Assists in maintaining material and components inventory level.

Requirements

• 0-3 years of demonstrated proficiency in common computer tools such as word processing, spreadsheet and web based applications.
• Experience with Manufacturing, cGMP environment, Use of hand tools
• Experience with process automation systems (i.e. Delta V and Syncade Interactions, Pi Vision) and some supporting business systems (i.e. SAP, Infinity, Maximo etc.).
• Work/study experience where attention to detail and personal accountability were critical to success
• High school diploma is required. Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is desired but not required.

Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.

Compensation: $35/hr. - $37.56/hr.