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Manufacturing Associate
7555 Harmans Road Severn, MD 21077 US
Job Description
The Manufacturing Associate I performs and documents cGMP activities to support upstream or downstream production areas and operations. This involves operation of process equipment, execution of validation protocols, completion of cGMP documents, creating/ revising cGMP documents and other assignments as directed.
Lifting to 40 lbs., unassisted may be required at times.
Frequent standing and walking is required, as this role requires presence on the manufacturing floor.
Shift work and weekend work is required.
Key Responsibilities include but are not limited to:
- Performs Processing Steps and/or Manufacturing Support activities, monitoring process against the batch record.
- Documents/Records cGMP data and information for processing steps and/or equipment activities, following standard operating procedures. Key documentation includes batch records and equipment logbooks.
- Understands basic cGMP requirements and follows those requirements, including requirements for good documentation practices.
- Completes /reviews validation protocols, deviation reports, change controls in accordance with cGMPs
- Performs the weighing, dispensing of raw materials for media and buffers
- Performs the preparation of small and large volume media and buffer solutions, filtration and transfer of product.
- Operates bench top equipment including pH, conductivity, osmo meters, pumps, tubing welders, filter integrity testers etc.
- Dispensing, labeling, transfer/staging of raw materials and parts
- Assembly/disassembly, cleaning and sterilization of components, parts and equipment
- Maintaining equipment, area and cleaning logbooks
- Cleaning sanitizing production rooms and equipment
- Stocking production and cleaning supplies
- May author/ review/improve SOPs, batch records, protocols and technical reports
- Actively participates in training activities, managing their individual training plan.
- Proficient and knowledgeable in the operation and basic troubleshooting of at least one manufacturing area.
- Other duties as assigned
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Education & Experience:
- High School Diploma with a minimum of 2-4 years GMP Manufacturing experience, OR
- Associates Degree in a scientific, engineering or biotechnology discipline with a minimum of 1-2 years related experience; coursework with biotechnology focus highly desirable, OR
- Bachelors Degree (BS/BA) from an accredited college or university with an emphasis in ascientific or engineering disciplineand some relevant work experience
- Basic knowledge of current Good Manufacturing Practices (cGMPs). Working knowledge of all relevant safety procedures within the company. General understanding of most areas in Manufacturing and supporting functional groups.
- Familiar with or experience with cGMP Biotech or Pharmaceutical operations:
- Must be team-oriented (proactively builds healthy working relationships between peers, their department and other groups).
- Able to fluently communicate in English. Exhibits excellent written and oral communication skills.
- Possesses a basic knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management.
PHYSICAL DEMANDS:
- Extended amount of time walking, standing, bending, reaching, pushing, and pulling.
Pay Rate Range: $20-28/hr depending on experience
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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