Amgen Sr Associate Mfg in Singapore, Singapore

Under general supervision, the Manufacturing Associate performs manufacturing unit operations according to Standard Operating Procedures in a cGMP (current Good Manufacturing Practices) manufacturing environment in support of the production of commercial pharmaceutical products.

Perform processes to support execution for the upstream, downstream and support operations on the shift

Use understanding of process theory to perform and monitor critical processes

Proficient in the operation and use of appropriate equipment in the area

Execute routine validation protocols

Set-up, clean and sanitize equipment and environment

Prepare media and/or buffers and other process materials

May assist with system ownership responsibilities

Identify and recommend improvements related to routine functions and implement after approval

Recognize & accurately report problems

Participate in resolving problems during operations

Document activities as appropriate (i.e., MPs and logs) using Good Documentation Practices (GDPs)

Will draft, own and revise documents (e.g., SOPs)

Assist in the review of documentation for assigned functions (e.g. equipment logs, routine area audits, batch records)

May train staff to perform hands-on tasks

Direct others on critical processes

Comply with and reinforce cGMPs and safety requirements

Understand and utilize Amgen's Quality Systems as appropriate, i.e. Nonconformance(NC), etc.

May interact with representatives of regulatory agencies.

Work within an ISO / EU classified environment while following the gowning requirements set forth for those areas

Aseptic manipulation of solutions and materials within classified environments

Decontamination, removal, and packaging of wastes for disposal

Job consists of occasional strenuous, repetitive work possible involving the following physical movements on a daily basis: bending, reaching above the head for long periods, climbing, kneeling, squatting, stooping, walking up stairs and standing on platforms up to 6 feet off of the ground and walking on wet surfaces.

Independently have the ability to regularly lift, push and/or pull items with an average weight of 25 pounds.

May require working around high pressure systems and in high/low temperature environments.

May work around loud equipment.

Use of personal protective equipment

Basic Qualifications

Master's degree OR Bachelor's degree & 2 years of experience directly related to the job

OR Associate's degree & 6 years of experience directly related to the job

OR High school diploma / GED & 8 years of experience directly related to the job

Preferred Qualifications

2 or more years experience with lab equipment, computers, and intermediate mathematical skills.

Ability to assemble, disassemble, operate and understand complex equipment per procedures.

Ability to perform basic computer operations, such as ability to navigate in MS Office, use email, and complete training using Computer Based Training (CBT).

Ability and willingness to work any shift in support of operations that may include 24/7.

Organizational skills and an ability to perform assignments with a high degree of attention to detail including documentation of work.

Capacity to follow written procedures, recognize and report malfunctions and make adjustments to equipment.

Written and oral communication skills.Under general supervision, the Manufacturing Associate performs manufacturing unit operations according to Standard Operating Procedures in a cGMP (current Good Manufacturing Practices) manufacturing environment in support of the production of commercial pharmaceutical products.

Perform processes to support execution for the upstream, downstream and support operations on the shift

Use understanding of process theory to perform and monitor critical processes

Proficient in the operation and use of appropriate equipment in the area

Execute routine validation protocols

Set-up, clean and sanitize equipment and environment

Prepare media and/or buffers and other process materials

May assist with system ownership responsibilities

Identify and recommend improvements related to routine functions and implement after approval

Recognize & accurately report problems

Participate in resolving problems during operations

Document activities as appropriate (i.e., MPs and logs) using Good Documentation Practices (GDPs)

Will draft, own and revise documents (e.g., SOPs)

Assist in the review of documentation for assigned functions (e.g. equipment logs, routine area audits, batch records)

May train staff to perform hands-on tasks

Direct others on critical processes

Comply with and reinforce cGMPs and safety requirements

Understand and utilize Amgen's Quality Systems as appropriate, i.e. Nonconformance(NC), etc.

May interact with representatives of regulatory agencies.

Work within an ISO / EU classified environment while following the gowning requirements set forth for those areas

Aseptic manipulation of solutions and materials within classified environments

Decontamination, removal, and packaging of wastes for disposal

Job consists of occasional strenuous, repetitive work possible involving the following physical movements on a daily basis: bending, reaching above the head for long periods, climbing, kneeling, squatting, stooping, walking up stairs and standing on platforms up to 6 feet off of the ground and walking on wet surfaces.

Independently have the ability to regularly lift, push and/or pull items with an average weight of 25 pounds.

May require working around high pressure systems and in high/low temperature environments.

May work around loud equipment.

Use of personal protective equipment

Basic Qualifications

Master's degree OR Bachelor's degree & 2 years of experience directly related to the job

OR Associate's degree & 6 years of experience directly related to the job

OR High school diploma / GED & 8 years of experience directly related to the job

Preferred Qualifications

2 or more years experience with lab equipment, computers, and intermediate mathematical skills.

Ability to assemble, disassemble, operate and understand complex equipment per procedures.

Ability to perform basic computer operations, such as ability to navigate in MS Office, use email, and complete training using Computer Based Training (CBT).

Ability and willingness to work any shift in support of operations that may include 24/7.

Organizational skills and an ability to perform assignments with a high degree of attention to detail including documentation of work.

Capacity to follow written procedures, recognize and report malfunctions and make adjustments to equipment.

Written and oral communication skills.