Cryogenic Process Specialist Job Harvard Massachusetts USA,Manufacturing / Production

Location: Harvard

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You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

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The Cryogenic Process Specialist assists in the execution of drug substance freezing, drug substance shipments, QC sample shipments and cell bank activities according to established work instructions and production records for the manufacture of therapeutic proteins in accordance with current Good Manufacturing Practices (cGMPs).

ROLE RESONSIBILITIES:

Role consists of performing operational and warehousing activities in Devens site Cryogenic facility. Activities include the freeze –thaw processing steps and packaging- shipping of bulk drug substances or cold chain samples in accordance with the defined process parameters and the business requirements of the Devens site.

Level of understanding is such that candidate has the ability to recognize deviation from accepted practice, and lead and train other team members.

Adheres to Good Manufacturing Practices and standard operating procedures.

Always works in a safe manner, following all safety processes, procedures and guidelines.

Maintains housekeeping and audit readiness at all times.

Is familiar with all aspects of Cryogenics Process operation, with ability to support and/or lead deviations and safety investigations.

Effectively uses and possess mastery for process automation systems (i.e. Delta V, OSI/Pi Historian, and MES Syncade) and supporting business systems (i.e. SAP. Infinity, Maximo etc.).

Ensures less experienced personnel comply with Standard Operating Procedures (SOPs) and work instructions and that training is completed on time.

Revises and creates process documents with no instructions, supports routine process investigations independently.

Reviews batch records for each manufacturing lot in conjunction with Quality representative. Resolves issues.

Champions areas specific initiatives associated with work safety.

Engages in and supports culture of continual improvement through ownership of improvement for work processes, equipment and safe work environment. Advises supervisor on improvements which may optimize work processes.

QUALIFICATIONS:

Associate’s degree is required;
Bachelor’s degree preferred with 4+ years of experience.
Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, is a plus.
A minimum of 4+ years operations experience in a facility subject to Good Manufacturing Practices (GMP) regulations.
Practical knowledge of regulations such as GMP and company Standard Operating Procedures (SOP).
Prior evidence of successful participation on work teams where combined contribution, collaboration, and results were expected
Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web based applications.
Previous work experience where attention to detail and personal accountability were critical to success
Demonstrates good interpersonal skills, is attentive and approachable.
Maintains a professional and productive relationship with area management and co-workers.

Compensation Overview:

Devens - MA - US: $33.51 - $40.61per hour

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account…