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Manufacturing Specialist
1 month ago
Summary
Arcadis DPS is looking for a full-time Manufacturing Specialist. Duties include processing in upstream and downstream operations while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which apply.
Due to the production schedule, the work schedule for this position varies month to month. Typical schedule demands are weekly Monday Friday as well as night, weekend, overtime, and shift coverage when necessary.
This is a fast-paced challenging position offering a competitive compensation and benefits package. This position will report directly to the Manager of Manufacturing and will be based at the facility in Boston (Seaport), MA.
Key Responsibilities
- Learn to operate manufacturing process equipment to perform various cell culture and purification production steps, and train co-workers on the operation of the equipment
- Operate inside of a BSC, sample, and perform with aseptic techniques
- Monitor and record batch parameters, including computer data entry
- Complete relevant paperwork following GDP/GMP guidelines including performing mathematical calculations related to production processes
- to operate cleaning and sanitization systems including glasswasher and autoclave systems, manually clean portable equipment and small parts, and train co-workers on the operation of the systems
- Perform routine maintenance and cleaning of production equipment to maintain equipment in GMP fashion
- Troubleshoot process problems and respond appropriately
- Provide information for unplanned events, including entering data into event management software
- Perform daily routine environmental monitoring
- Order, receive, and distribute supplies into production area
- Schedule department or process activities and demonstrate procedures as a part of training sessions for team members
- Participate in and lead team meetings as well as facilitate multidepartment discussions
- Participate on continuous improvement teams Follow all established occupational health and safety procedures, good manufacturing practices (GMPs) and standard operating procedures (SOPs)
- Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
- Perform ad-hoc work/special projects as necessary to support on various business initiatives
- Comfortable working independently with minimal supervision
- Highly organized, results driven, problem solver, and collaborator
- Demonstrated ability to perform the essential duties of the position with or without accommodation
Skills & Qualifications
- Bachelors degree in life science or Associates degree with two (2) years relevant experience preferred
- Biotech certificate preferred
- Demonstrated knowledge of cGMP manufacturing is a plus
- Knowledge of laboratory and pharmaceutical production equipment including but not limited to autoclaves, process tanks, cell culture equipment, chromatography skids and columns, analytical equipment
- Proficiency in a variety of mathematical disciplines and able to work with metric and USA standards of measurement, and military time
- Solid verbal and written communication skills with the ability to read and follow detailed English written instructions
- Ability to write legibly and grammatically correct entries on records and must be able to author technical procedures and create manufacturing forms
- Familiar with standard troubleshooting approaches such as problem statement, root cause analysis, and corrections
- Knowledge of basic chemical and biological safety procedures
- Solid computer skills, knowledge of Microsoft Word and Excel
- Good interpersonal skills and ability to work effectively and efficiently in a team environment
- Ability to work during general business hours Monday Friday as well as flexibility to work nights, weekends, holidays, overtime and shift work as dictated by the 365-day per year production schedule
- Ability to work in a clean room environment and comply with hygiene standards and use of special garments, including wearing personal protective equipment as per safety requirements
- Dedicated team player who can withstand the high demands of a fast-paced environment
- Excellent written and verbal communication skills are essential
- Strong planning and organizational skills
The Company
Arcadis DPS Group is a global EPCM firm offering full-service solutions within the Life Sciences (pharmaceutical, biotechnology, and medical technology) and Advanced Technology (semiconductor, data center, and solar) industries. DPS is dedicated to delivering successful projects with a client-first mentality and personal touch across a range of market sectors: Project and Program Management, Procurement, Design, Construction Management, Health and Safety Management, Commissioning, Qualification, and Start-up.
Arcadis DPS Engineering Inc. is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities.DPS does not discriminate in employment opportunities or practices on the basis of: race, color, religion, gender, national origin, age, sexual orientation, gender identity, disability, veteran status or any other characteristic protected by country, regional or local law.
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