Job Description

Summary of Key Responsibilities

• Operate manufacturing equipment and other manufacturing instruments.
• Ensure process equipment is appropriately maintained for operation.
• Perform and document operations in accordance with cGMP’s.
• Execute equipment qualification protocols and validation protocols.
• Routinely draft and revise standard operating procedures and master batch records.
• Recognize and initiate process deviation reviews.
• Support continuous improvement initiatives by identifying areas needing improvement, recommending strategies for improvement, and implementing those strategies once approved.
• Ability to communicate effectively, both in written & oral terms.
• Conduct daily activities in an organized, efficient manner.
• Perform simple, routine, complex, and critical operations.
• Troubleshoot equipment issues, when necessary.
• Maintain training compliance.
• Ensure a safe working environment for all staff.

Required Qualifications and Skills

• A.A.S. in a scientific discipline, or equivalent experience preferred.
• 0 – 3 years' experience in a cGMP biopharmaceutical manufacturing environment.
• Able to function, with guidance, in a rapidly changing environment while balancing multiple priorities simultaneously.
• Must be able to work within and adapt to electronic systems.
• Able to work in an intense, fast-paced work environment.
• Able to work independently and as part of a team.
• Must be able to read, write and converse in English.
• Must have a good working knowledge of MS Office (Outlook, Word and Excel).

Physical Demands and Work Environment

• While performing the duties of this job, there may be certain physical demands required for the position.
• Requires constant standing, walking, seeing, & hearing
• Requires occasional sitting
• Requires constant carrying & lifting; frequently under 20 LBS, 20-60 LBS, & occasionally over 60 LBS
• Requires frequent bending, twisting, gripping, & reaching
• Requires frequent pushing & pulling under 20 LBS, 20-60 LBS, & occasionally over 60 LBS

Other Duties

You may be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked.

Limitations and Disclaimer

The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position. The Company is committed to making reasonable adjustments to the workplace to ensure the role is accessible to all candidates, including those with disabilities. To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.