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Process Engineer

Berkshire Sterile Manufacturing

Lee, MA | Full Time

$83k-97k (estimate)

0 Months Ago

Process Engineer

$83k-97k (estimate)

Full Time | Pharmaceutical 0 Months Ago

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Berkshire Sterile Manufacturing is Hiring a Process Engineer Near Lee, MA

Position Summary	The Process Engineer will lead tech transfer projects from client or small scale to manufacturing/large scale in a manner that meets safety, quality, and operational performance expectations. The key function of this role will be to deliver effective, safe and efficient manufacturing processes for parenteral drug products.
Duties and Responsibilities	Layout manufacturing process flow for parenteral drug products based on tech transfer information Identify and order materials required to perform development and manufacturing Identify tooling and equipment required to perform development and manufacturing Develop and execute study protocols to evaluate manufacturing processes and write associated reports Develop and execute batch records defining bill of materials and manufacturing processes Develop SOPs for equipment operations Design and execute performance qualification of instruments Identify technical issues and provide necessary solutions to determine root cause Work with operations, engineering, QA, maintenance, suppliers and management to resolve problems Accurately document and record necessary data and reports with appropriate conclusions Complete quality events such as deviation with sound judgement and scientific principal Provide feedback on process improvement initiatives to improve operating performance Maintain knowledge of equipment and manufacturing technology changes and core process technologies Source equipment and develop processes that meet safety requirements and provide for the safety and well-being of operators, maintenance, and other personnel Other duties as assigned
Regulatory Responsibilities	N/A
Supervisory Responsibilities	N/A
Experience	One (1) to three (3) years in a pharmaceutical environment
Education	Process Engineer: Bachelor’s degree in Chemical Engineering, Chemistry, Biology, or Pharmaceutical Science
Knowledge, Skills & Abilities	Solid working knowledge in the application of engineering principles, scientific analysis Able to perform routine and complex work instructions under limited supervision Able to perform routine problem solving referring complex problems to supervisor Calculation, data analysis, statistics and applied mathematics Project management Mechanical aptitude Microsoft Office, Visio or other related software Excellent writing skills Attention to detail Oral communication skills
Physical Requirements	Ability to meet gowning requirements Ability to remain stationary for prolonged periods of time Able to periodically lift up to 50lbs Satisfactory audio-visual acuity Gross and fine motor skills to manipulate instruments

Job Summary

JOB TYPE

Full Time

INDUSTRY

Pharmaceutical

SALARY

$83k-97k (estimate)

POST DATE

05/11/2023

EXPIRATION DATE

05/11/2024

WEBSITE

berkshiresterilemanufacturing.com

HEADQUARTERS

LEE, MA

SIZE

100 - 200

FOUNDED

2014

TYPE

Private

CEO

SHAWN KINNEY

REVENUE

$10M - $50M

INDUSTRY

Pharmaceutical

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About Berkshire Sterile Manufacturing

BSM is a bio-pharmaceutical company that develops and manufactures sterile drug products for clinical applications.

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The following is the career advancement route for Process Engineer positions, which can be used as a reference in future career path planning. As a Process Engineer, it can be promoted into senior positions as a Chemical Process Engineer III that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Process Engineer. You can explore the career advancement for a Process Engineer below and select your interested title to get hiring information.